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Protocol summary
This study will be performed in the midwifery clinic of Shahid Hosseinpour Hospital in Langarud. Twenty minutes before performing the NST, four drops of 10% Lavender essential oil will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes.
In aroma and music group simultaneously with Lavender aroma, the music (sounds of nature) will be played through headphones for 20 minutes. In the control group, distilled water as a placebo will be used Instead of aroma. For mothers of aroma and control groups, headphones will be placed without playing music to eliminate the ambient sounds. After 20 minutes implementation of intervention, the NST will be performed for all mothers
This study will be performed in the prenatal clinic of Shahid Akbar-abadi Hospital in Tehran. Twenty minutes before performing the NST, four drops of 10% Lavender essential oil will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes.
In aroma and music group simultaneously with Lavender aroma, the music (sounds of nature) will be played through headphones for 20 minutes. In the control group, distilled water as a placebo will be used Instead of aroma. For mothers of aroma and control groups, headphones will be placed without playing music to eliminate the ambient sounds. After 20 minutes implementation of intervention, the NST will be performed for all mothers
This study will be performed in the midwiferyprenatal clinic of Shahid HosseinpourAkbar-abadi Hospital in LangarudTehran. Twenty minutes before performing the NST, four drops of 10% Lavender essential oil will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes. In aroma and music group simultaneously with Lavender aroma, the music (sounds of nature) will be played through headphones for 20 minutes. In the control group, distilled water as a placebo will be used Instead of aroma. For mothers of aroma and control groups, headphones will be placed without playing music to eliminate the ambient sounds. After 20 minutes implementation of intervention, the NST will be performed for all mothers
این مطالعه در درمانگاه مامایی بیمارستان شهید حسین پور لنگرود انجام خواهد شد. 20 دقیقه قبل از انجام آزمون بدون استرس جنین، در گروه رایحه، 4 قطره رایحه اسطوخودوس 10 درصد بر روی یک دستمال پلی اتیلن 10*10 چکانده شده و به یقه‌ی لباس مادر متصل می‌گردد. در گروه رایحه – موسیقی، بطور همزمان همراه با رایحه اسطوخودوس، به مدت 20 دقیقه از طریق هدفون موسیقی (صداهای طبیعت) پخش خواهد شد. در گروه کنترل به جای رایحه از آب مقطر به عنوان دارونما استفاده خواهد شد. برای مادران هر دو گروه رایحه و گروه کنترل جهت حذف صداهای محیط، هدفون بدون پخش موسیقی گذاشته خواهد شد. پس از 20 دقیقه اجرای مداخله، آزمون بدون استرس جنین برای تمامی مادران انجام خواهد شد.
این مطالعه در درمانگاه پره ناتال بیمارستان شهید اکبرآبادی تهران انجام خواهد شد. 20 دقیقه قبل از انجام آزمون بدون استرس جنین، در گروه رایحه، 4 قطره رایحه اسطوخودوس 10 درصد بر روی یک دستمال پلی اتیلن 10*10 چکانده شده و به یقه‌ی لباس مادر متصل می‌گردد. در گروه رایحه – موسیقی، بطور همزمان همراه با رایحه اسطوخودوس، به مدت 20 دقیقه از طریق هدفون موسیقی (صداهای طبیعت) پخش خواهد شد. در گروه کنترل به جای رایحه از آب مقطر به عنوان دارونما استفاده خواهد شد. برای مادران هر دو گروه رایحه و گروه کنترل جهت حذف صداهای محیط، هدفون بدون پخش موسیقی گذاشته خواهد شد. پس از 20 دقیقه اجرای مداخله، آزمون بدون استرس جنین برای تمامی مادران انجام خواهد شد.
این مطالعه در درمانگاه ماماییپره ناتال بیمارستان شهید حسین پور لنگروداکبرآبادی تهران انجام خواهد شد. 20 دقیقه قبل از انجام آزمون بدون استرس جنین، در گروه رایحه، 4 قطره رایحه اسطوخودوس 10 درصد بر روی یک دستمال پلی اتیلن 10*10 چکانده شده و به یقه‌ی لباس مادر متصل می‌گردد. در گروه رایحه – موسیقی، بطور همزمان همراه با رایحه اسطوخودوس، به مدت 20 دقیقه از طریق هدفون موسیقی (صداهای طبیعت) پخش خواهد شد. در گروه کنترل به جای رایحه از آب مقطر به عنوان دارونما استفاده خواهد شد. برای مادران هر دو گروه رایحه و گروه کنترل جهت حذف صداهای محیط، هدفون بدون پخش موسیقی گذاشته خواهد شد. پس از 20 دقیقه اجرای مداخله، آزمون بدون استرس جنین برای تمامی مادران انجام خواهد شد.
General information
2021-01-09, 1399/10/20
2021-02-08, 1399/11/20
2021-0102-0908 00:00:00
2021-12-01, 1400/09/10
2021-08-22, 1400/05/31
2021-1208-0122 00:00:00
empty
To Change the sampling location, also start and end time of sampling
To Change the sampling location, also start and end time of sampling
empty
تغییر محل نمونه گیری - هم چنین زمان شروع و پایان نمونه گیری
تغییر محل نمونه گیری - هم چنین زمان شروع و پایان نمونه گیری
Recruitment centers
#1
Name of recruitment center - English: Shahid Hossein pour hospital
Name of recruitment center - Persian: بیمارستان شهید حسین پور
Full name of responsible person - English: Nasrin Rezaee
Full name of responsible person - Persian: نسرین رضایی
Street address - English: Shahid Hosein pour hospital , Gilan, Langarud,shora st
Street address - Persian: بیمارستان شهید حسین پور، گیلان، لنگرود، خیابان شورا
City - English: Langarud
City - Persian: لنگرود
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 00989113425568
Phone: +98 13 4256 4004
Fax:
Email: nasrin.r1327@gmail.com
Web page address:
Name of recruitment center - English: Shahid Akbar-abadi hospital
Name of recruitment center - Persian: بیمارستان شهید اکبرآبادی
Full name of responsible person - English: Nasrin Rezaei
Full name of responsible person - Persian: نسرین رضائی
Street address - English: Mowlavi St. Tehran, Iran
Street address - Persian: تهران، خیابان مولوی، تهران، ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1168743514
Phone: +98 21 5560 6034
Fax:
Email: nasrin.r1327@gmail.com
Web page address:
Name of recruitment center - English: Shahid Hossein pourAkbar-abadi hospital Name of recruitment center - Persian: بیمارستان شهید حسین پوراکبرآبادی Full name of responsible person - English: Nasrin RezaeeRezaei Full name of responsible person - Persian: نسرین رضاییرضائی Street address - English: Shahid Hosein pour hospital Mowlavi St. Tehran, Gilan, Langarud,shora stIran Street address - Persian: بیمارستان شهید حسین پور، گیلان، لنگرودتهران، خیابان شورامولوی، تهران، ایران City - English: LangarudTehran City - Persian: لنگرودتهران Province: GuilanTehran Country: Iran (Islamic Republic of) Postal code: 009891134255681168743514 Phone: +98 13 4256 400421 5560 6034 Fax: Email: nasrin.r1327@gmail.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: نسرین رضایی
Full name of responsible person - Persian: Nasrin Rezaee
Position - English: Midwife
Position - Persian: ماما
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: salamat Hospital, Gilan, Rostam abad, end of Shahid Beheshti Boulevard
Street address - Persian: بیمارستان سلامت، گیلان،رستم آباد، انتهای بلوار شهید بهشتی
City - English: Rostam abad
City - Persian: رستم آباد
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4464137787
Phone: +98 13 3467 5526
Mobile: +98 911 342 5568
Fax:
Email: nasrin.r1327@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: نسرین رضائی
Full name of responsible person - Persian: Nasrin Rezaei
Position - English: Midwife
Position - Persian: ماما
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: salamat Hospital, Gilan, Rostam abad, end of Shahid Beheshti Boulevard
Street address - Persian: بیمارستان سلامت، گیلان،رستم آباد، انتهای بلوار شهید بهشتی
City - English: Rostam abad
City - Persian: رستم آباد
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4464137787
Phone: +98 13 3467 5526
Mobile: +98 911 342 5568
Fax:
Email: nasrin.r1327@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: نسرین رضاییرضائی Full name of responsible person - Persian: Nasrin RezaeeRezaei Position - English: Midwife Position - Persian: ماما Latest degree: bachelor Area of specialty/work: 1 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: salamat Hospital, Gilan, Rostam abad, end of Shahid Beheshti Boulevard Street address - Persian: بیمارستان سلامت، گیلان،رستم آباد، انتهای بلوار شهید بهشتی City - English: Rostam abad City - Persian: رستم آباد Province: Guilan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 4464137787 Phone: +98 13 3467 5526 Mobile: +98 911 342 5568 Fax: Email: nasrin.r1327@gmail.com Web page address:
Protocol summary
Study aim
Comparison of aromatherapy and music on the Non-Stress Test (NST) and anxiety in primiparous women.
Design
This study is a randomized, single-blind three-group clinical trial (two intervention groups and one control group - 65 participants in each group). Random sampling will be performed using six blocks among primiparous women who referred to performing NST for the first time.
Settings and conduct
This study will be performed in the prenatal clinic of Shahid Akbar-abadi Hospital in Tehran. Twenty minutes before performing the NST, four drops of 10% Lavender essential oil will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes.
In aroma and music group simultaneously with Lavender aroma, the music (sounds of nature) will be played through headphones for 20 minutes. In the control group, distilled water as a placebo will be used Instead of aroma. For mothers of aroma and control groups, headphones will be placed without playing music to eliminate the ambient sounds. After 20 minutes implementation of intervention, the NST will be performed for all mothers
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian primiparous women, Gestational age of 32 to 41 weeks of pregnancy.
Exclusion criteria: a history of infertility, mental illness.
Intervention groups
Aromatherapy group= Aromatherapy will be done with 10% Lavender essential oil. To eliminate the ambient sounds, headphones will be placed without playing music.
Aromatherapy- music group = Simultaneously with the aroma of lavender, sounds of nature selected by mother will be played through headphones for 20 minutes.
Control group=Distilled water will be used Instead of aroma, as a placebo, also to eliminate the ambient sounds, headphones will be placed without playing music.
Main outcome variables
State anxiety, trait anxiety, results of non – stress test.
General information
Reason for update
To Change the sampling location, also start and end time of sampling
Acronym
IRCT registration information
IRCT registration number:IRCT20090810002324N17
Registration date:2020-12-22, 1399/10/02
Registration timing:prospective
Last update:2021-01-10, 1399/10/21
Update count:1
Registration date
2020-12-22, 1399/10/02
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-08, 1399/11/20
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of aromatherapy and music on the Non-Stress Test and anxiety in primiparous women.
Public title
Aromatherapy and music on the Non-Stress Test and anxiety.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Maternal age 18 - 40 years.
Gestational age of 32 - 41 weeks of pregnancy (from accurate Last menstruation period or first - trimester ultrasound).
Wanted pregnancy.
Stable hemodynamic status in mother (blood pressure higher than 80/60 mm/Hg).
passage of at least 1.5 - 2 hours from the last meal.
Exclusion criteria:
History of infertility or the use of assisted reproductive techniques.
Vaginal bleeding and uterine contraction.
Any fetal abnormalities and amniotic fluid disorders.
Using painkillers and sedatives in the last 24 hours.
Hearing disorders.
Addiction to drugs, psychotropic substances, and cigarettes.
Neurological problems.
Respiratory diseases and a history of allergies to plant essential oils.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
195
Randomization (investigator's opinion)
Randomized
Randomization description
Each of the two intervention and the control groups will be assigned one of the codes A, B or C. Randomization will be done using six blocks and determination of blocks will be done using R statistical program. For concealment, each block will be placed in an opaque envelope. Each envelope will be randomly selected by one of the study participants. Participants will be placed in one of the two intervention or the control groups based on the codes in each of the specified blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Interpretation of non - stress tests in all groups will be done by two research assistants (Specialist in perinatology) who unaware of the group's allocation. All questionnaires will be gathered by the research assistant who unaware of the group's allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی ایران
Street address
تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-10-21, 1399/07/30
Ethics committee reference number
IR.IUMS.REC.1399.675
Health conditions studied
1
Description of health condition studied
State and trait anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The mean Score and severity of State anxiety of Spielberger questionnaire.
Timepoint
Before the intervention, 15 minutes after the end of NST.
Method of measurement
The State anxiety of Spielberger questionnaire.
2
Description
The mean score and severity of trait anxiety of Spielberger questionnaire.
Timepoint
Before the intervention, after the end of NST.
Method of measurement
The trait anxiety of Spielberger questionnaire.
3
Description
reactive and non- reactive of NST.
Timepoint
After the end of NST.
Method of measurement
Checklist
4
Description
The number of acceleration of fetal heart rate.
Timepoint
During the NST Procedure.
Method of measurement
Checklist
5
Description
The number of fetal movement.
Timepoint
During the NST Procedure.
Method of measurement
Checklist
6
Description
Minimum time for the test to be positive.
Timepoint
During the NST Procedure.
Method of measurement
Checklist
Secondary outcomes
1
Description
Blood pressure
Timepoint
Measuring the blood pressure will be done in a sitting position before performing the intervention. After completing the NST, on the left side of the supine position, the blood pressure will be re-measured.
Method of measurement
Digital sphygmomanometer
Intervention groups
1
Description
Intervention group: The first Intervention group aromatherapy: At first, the mother will be placed in a quiet room. Twenty minutes before performing the non-stress test (NST), four drops of 10% Lavender essential oil (Made by the Barij Essence Pharmaceutical Company) will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes. For the mothers of this group, to eliminate the ambient sounds, headphones will be placed without playing music. The mother will typically inhale the aroma for 20 minutes. After removing the Polyethylene napkin and headphones, the mother will be ready for the test. The NST will be performed for 20 minutes using a Fetal monitoring device.
Category
Prevention
2
Description
Intervention group: aromatherapy and music: At first, the mother will be placed in a quiet room. Twenty minutes before performing the NST, four drops of 10% Lavender essential oil (Made by the Barij Essence Pharmaceutical Company) will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes. Simultaneously with the aroma of lavender, the music (sounds of nature) will be played through headphones for 20 minutes by selecting the type of music and the volume of the tuning sound according to the mother's desire (with a maximum of 45 dB). After removing the Polyethylene napkin and headphones, the mother will be ready for the test. The NST will be performed for 20 minutes using a Fetal monitoring device.
Category
Prevention
3
Description
Control group: At first, the mother will be placed in a quiet room. Twenty minutes before performing the NST, four drops of distilled water, as a placebo, will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes. The mother will typically inhale it for 20 minutes. For the mothers of this group, to eliminate the ambient sounds, headphones will be placed without playing music. After removing the Polyethylene napkin and headphones, the mother will be ready for the test. The NST will be performed for 20 minutes using a Fetal monitoring device.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar-abadi hospital
Full name of responsible person
Nasrin Rezaei
Street address
Mowlavi St. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
nasrin.r1327@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
کاظم ملکوتی
Street address
تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
Email
vcm@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 43651813
Email
keshavarz.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
1996713883
Email
keshavarz.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
نسرین رضائی
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
salamat Hospital, Gilan, Rostam abad, end of Shahid Beheshti Boulevard
City
Rostam abad
Province
Guilan
Postal code
4464137787
Phone
+98 13 3467 5526
Email
nasrin.r1327@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available