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The effect of relaxation technique on anxiety and hemodynamic parameters in women before cesarean section

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History
# Registration date Revision Id
2 2024-09-07, 1403/06/17 313638
1 2020-08-05, 1399/05/15 145931
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  • Protocol summary

    All mothers waiting for cesarean section who are at least 18 and at most 36 years old, have no hearing loss, muscle paralysis, thyroid disorder, known mental illness and previous history of cesarean section and similar courses of muscle relaxation, sedative use in the last 24 hours and ability to understand Persian language.
    All mothers waiting for cesarean section who are at least 18 and at most 36 years old, have no hearing loss, muscle paralysis, thyroid disorder, known mental illness and previous history of cesarean section and similar courses of muscle relaxation, sedative use in the last 24 hours and ability to understand Persian language and obtaining an anxiety score of 7 and above from the hospital anxiety tool.
    کلیه مادران در انتظار سزارین که حداقل 18 و حداکثر 36 سال سن، نداشتن مشکل شنوایی ، فلج عضلانی ، اختلال تیروئیدی، بیماری روانی شناخته شده و سابقه قبلی سزارین و دوره های مشابه آرام سازی عضلانی، مصرف آرامبخش طی 24 ساعت گذشته و داشتن توانایی فهم زبان فارسی، می باشد.
    کلیه مادران در انتظار سزارین که حداقل 18 و حداکثر 36 سال سن، نداشتن مشکل شنوایی ، فلج عضلانی ، اختلال تیروئیدی، بیماری روانی شناخته شده و سابقه قبلی سزارین و دوره های مشابه آرام سازی عضلانی، مصرف آرامبخش طی 24 ساعت گذشته و داشتن توانایی فهم زبان فارسی،کسب نمره اضطراب 7 به بالا از ابزار اضطراب بیمارستانی می باشد.
    Intervention group of 54 people (routine care with relaxation)
    Intervention group of 31 people (routine care with relaxation)
    گروه 54 نفره مداخله (مراقبت معمول همراه با اجرای آرام سازی)
    گروه 31 نفره مداخله (مراقبت معمول همراه با اجرای آرام سازی)

  • General information

    108
    62
    108
    62
    empty
    The change in the sample size is due to the change in the conditions of inclusion in the study of this edition.
    empty
    تغییر در حجم نمونه به دلیل تغییر شرایط معیار ورود به مطالعه این ویرایش صورت می گیرد.
    The samples of this study included 108 eligible mothers with the consent of participating in the study, based on the allocation sequence produced by block method in volume 4, were randomly assigned to the study and control groups.For secrecy of the allocation sequence, since the two sample centers were collected simultaneously, the central secrecy method was used.Thus, the allocation sequence was in the hands of an individual outside the research team, and the relevant expert in each center, after registering the participants for the allocation of each individual, contacted the individual and assigned the participant to the intervention or control group.
    The samples of this study included 62 eligible mothers with the consent of participating in the study, based on the allocation sequence produced by block method in volume 4, were randomly assigned to the study and control groups.For secrecy of the allocation sequence, since the two sample centers were collected simultaneously, the central secrecy method was used.Thus, the allocation sequence was in the hands of an individual outside the research team, and the relevant expert in each center, after registering the participants for the allocation of each individual, contacted the individual and assigned the participant to the intervention or control group.
    نمونه های این مطالعه شامل 108 مادر واجدالشرایط با رضایت شرکت در مطالعه، بر اساس توالی تخصیص تولید شده به روش بلوکی به حجم 4، به دو گروه مطالعه و کنترل بطور تصادفی اختصاص یافتند. برای نهان سازی توالی تخصیص از آنجاییکه بطور همزمان از دو مرکز نمونه هاجمع آوری می شد، از روش نهان سازی مرکزی استفاده شد. بدین ترتیب که توالی تخصیص در دست فردی خارج تیم تحقیق قرار داشت و کارشناس مربوطه در هر مرکز بعد از ثبت نام شرکت کنندگان برای تخصیص هر فرد، با فرد مورد نظر تماس گرفته و شرکت کننده را به گروه مداخله یا کنترل اختصاص می داد.
    نمونه های این مطالعه شامل 62 مادر واجدالشرایط با رضایت شرکت در مطالعه، بر اساس توالی تخصیص تولید شده به روش بلوکی به حجم 4، به دو گروه مطالعه و کنترل بطور تصادفی اختصاص یافتند. برای نهان سازی توالی تخصیص از آنجاییکه بطور همزمان از دو مرکز نمونه هاجمع آوری می شد، از روش نهان سازی مرکزی استفاده شد. بدین ترتیب که توالی تخصیص در دست فردی خارج تیم تحقیق قرار داشت و کارشناس مربوطه در هر مرکز بعد از ثبت نام شرکت کنندگان برای تخصیص هر فرد، با فرد مورد نظر تماس گرفته و شرکت کننده را به گروه مداخله یا کنترل اختصاص می داد.

  • Recruitment centers

    #1
    Name of recruitment center - English: بیمارستان بهار، بیمارستان خاتم الانبیا
    Name of recruitment center - Persian: Bahar Hospital, Khatam Al-Anbia Hospital
    Full name of responsible person - English: منصوره خیری
    Full name of responsible person - Persian: Mansoure kheiri
    Street address - English: Imam Town, Akhavan Sharif St. No. 122
    Street address - Persian: شهرک امام، خیابان اخوان شریف پلاک 122
    City - English: Shahroud
    City - Persian: شاهرود
    Province: Semnan
    Country: Iran (Islamic Republic of)
    Postal code: 3614775911
    Phone: +98 23 3239 1144
    Fax:
    Email: kheiri_mansoure@yahoo.com
    Web page address:
    Name of recruitment center - English: Bahar Educational, Research and Treatment Center
    Name of recruitment center - Persian: مرکز آموزشی، پژوهشی و درمانی بهار
    Full name of responsible person - English: Mansoure kheiri
    Full name of responsible person - Persian: منصوره خیری
    Street address - English: 22 Bahman Street in front of the children's park
    Street address - Persian: خیابان ۲۲ بهمن روبروی پارک کودک
    City - English: Shahroud
    City - Persian: شاهرود
    Province: Semnan
    Country: Iran (Islamic Republic of)
    Postal code: 3614775911
    Phone: +98 23 3224 7648
    Fax:
    Email: kheiri_mansoure@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: دکتر حمیدکلالیان
    Full name of responsible person - Persian: Dr hamid kalalian
    Street address - English: Imam Town, Akhavan Sharif St. No. 122
    Street address - Persian: شهرک امام، خیابان اخوان شریف،پلاک 122
    City - English: Shahroud
    City - Persian: شاهرود
    Province: Semnan
    Country: Iran (Islamic Republic of)
    Postal code: 3614775911
    Phone: +98 23 3239 1144
    Fax:
    Email: kheiri_mansoure@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Hamid Kalalian
    Full name of responsible person - Persian: دکتر حمید کلالیان
    Street address - English: Deputy of Management and Resources Development, Alborz Building, Corner of Ayatollah Behjat St., Fazlollah Nouri Blvd., Alborz Tow
    Street address - Persian: شهرك البرز- بلوار فضل الله نوري- نبش خیابان آيت الله بهجت ساختمان البرز- معاونت توسعه مدیریت و منابع
    City - English: Shahroud
    City - Persian: شاهرود
    Province: Semnan
    Country: Iran (Islamic Republic of)
    Postal code: 3717747667
    Phone: +98 23 3239 1817
    Fax:
    Email: h.kalalian@gmail.com
    Web page address:

Protocol summary

Study aim
Determining the effect of Benson relaxation method on anxiety and hemodynamic parameters in women before cesarean section
Design
It is a two-group clinical trial in which the study population consists of all mothers waiting for cesarean section.
Settings and conduct
Receiving face-to-face relaxation training by the researcher to hospitalized mothers waiting for cesarean section and listening to the relaxation audio file at least 3 times before cesarean section Bahar and Khatam Al-Anbia Educational, Research and Treatment Centers
Participants/Inclusion and exclusion criteria
All mothers waiting for cesarean section who are at least 18 and at most 36 years old, have no hearing loss, muscle paralysis, thyroid disorder, known mental illness and previous history of cesarean section and similar courses of muscle relaxation, sedative use in the last 24 hours and ability to understand Persian language and obtaining an anxiety score of 7 and above from the hospital anxiety tool.
Intervention groups
Intervention group of 31 people (routine care with relaxation)
Main outcome variables
Anxiety; blood pressure; Pulse rate; Number of breaths

General information

Reason for update
The change in the sample size is due to the change in the conditions of inclusion in the study of this edition.
Acronym
IRCT registration information
IRCT registration number: IRCT20200718048128N1
Registration date: 2020-08-05, 1399/05/15
Registration timing: retrospective

Last update: 2024-09-07, 1403/06/17
Update count: 1
Registration date
2020-08-05, 1399/05/15
Registrant information
Name
Mansoure Kheiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 1144
Email address
kheiri_2014@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-02, 1397/10/12
Expected recruitment end date
2019-07-03, 1398/04/12
Actual recruitment start date
2019-01-02, 1397/10/12
Actual recruitment end date
2020-01-02, 1398/10/12
Trial completion date
2020-01-02, 1398/10/12
Scientific title
The effect of relaxation technique on anxiety and hemodynamic parameters in women before cesarean section
Public title
The effect of Benson relaxation technique on anxiety and hemodynamic parameters in women before cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All mothers are waiting for a cesarean section
Exclusion criteria:
History of previous cesarean section
Age
From 18 years old to 36 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Actual sample size reached: 62
Randomization (investigator's opinion)
Randomized
Randomization description
The samples of this study included 62 eligible mothers with the consent of participating in the study, based on the allocation sequence produced by block method in volume 4, were randomly assigned to the study and control groups.For secrecy of the allocation sequence, since the two sample centers were collected simultaneously, the central secrecy method was used.Thus, the allocation sequence was in the hands of an individual outside the research team, and the relevant expert in each center, after registering the participants for the allocation of each individual, contacted the individual and assigned the participant to the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences and Health Services, Haftam Tir Square
City
Shahroud
Province
Semnan
Postal code
36147073947
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.SHMU.REC.1395.101

Health conditions studied

1

Description of health condition studied
cesarean section
ICD-10 code
P03.4
ICD-10 code description
Newborn (suspected to be) affected by Cesarean delivery

Primary outcomes

1

Description
Anxiety
Timepoint
The experimental group listened to the audio file of the relaxation training for 6 minutes and at least 3 times before the operation, 3-5 hours before cesarean section (the beginning of relaxation training is from the beginning of the morning, which does not interfere with the patient's sleep). He will practice Benson according to the instructions on the relaxation bar.
Method of measurement
Hospital Anxiety and Depression Scale (Anxiety Questions Only) and Hemodynamic Information Form

Secondary outcomes

1

Description
Hemodynamic indicators
Timepoint
The experimental group listened to the audio file of the relaxation training for 6 minutes and at least 3 times before the operation, 3-5 hours before cesarean section (the beginning of relaxation training is from the beginning of the morning, which does not interfere with the patient's sleep). He will practice Benson according to the instructions on the relaxation bar.
Method of measurement
Hemodynamic information form

Intervention groups

1

Description
Intervention group: All mothers waiting for cesarean section admitted to the educational-medical center (routine care with relaxation). The intervention group, after receiving face-to-face training of the relaxation method by the researcher and gaining the researcher's confidence in learning this method, listened to an audio file of relaxation training 3-5 hours before cesarean section and at least 3 times before cesarean section according to the instructions. Spread on a Benson muscle relaxation tape will practice (start relaxation training early in the morning that does not interfere with the patient's sleep)
Category
Behavior

2

Description
Control group: The control group also receives routine ward care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahar Educational, Research and Treatment Center
Full name of responsible person
Mansoure kheiri
Street address
22 Bahman Street in front of the children's park
City
Shahroud
Province
Semnan
Postal code
3614775911
Phone
+98 23 3224 7648
Email
kheiri_mansoure@yahoo.com

2

Recruitment center
Name of recruitment center
Khatam Al-Anbia Hospital (PBUH) Shahroud
Full name of responsible person
Mansoure kheiri
Street address
University Boulevard - in front of the University of Technology - Khatam Al-Anbia One Hundred Bed Hospital (PBUH)
City
Shahroud
Province
Semnan
Postal code
3614871151
Phone
+98 23 3233 9661
Email
kheiri_mansoure@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Hamid Kalalian
Street address
Deputy of Management and Resources Development, Alborz Building, Corner of Ayatollah Behjat St., Fazlollah Nouri Blvd., Alborz Tow
City
Shahroud
Province
Semnan
Postal code
3717747667
Phone
+98 23 3239 1817
Email
h.kalalian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mansoure Kheiri
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences and Health Services, 7th of Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
kheiri_2014@shmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mansoure Kheiri
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences and Health Services, 7th of Tir Square
City
Shahroud
Province
Semnan
Postal code
3614775911
Phone
+98 23 3239 1144
Email
kheiri_2014@shmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mansoure Kheiri
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences and Health Services, 7th of Tir Square
City
Shahroud
Province
Semnan
Postal code
3614775911
Phone
+98 23 3239 1144
Email
kheiri_2014@shmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It has not been in the methodology.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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