عنوان طرح(انگلیسی) Investigating the effect of regular breathing on anxiety of mothers with premature infant hospitalized in the Neonatal Intensive Care Unit
Determining the effect of regular breathing on the anxiety of mothers with premature babies admitted to the nicu
Design
A clinical trial with a control group, with parallel groups, randomized, phase 2 on 66 patients, Random Allocation software was used for randomization
Settings and conduct
This research will be conducted in the neonatal intensive care unit of Shahid Sadoughi Hospital, Yazd, on 66 mothers with premature infant.
Participants/Inclusion and exclusion criteria
The gestational age is 26 to 36 weeks and the mother does not have experience in hospitalization of premature babies and does not work in a medical environment.
Intervention groups
The control group, after completing the demographic information questionnaire and checking the entry criteria, if they are eligible, entered the study and completed the Spielberger Anxiety Questionnaire, and the intervention was carried out in the aforementioned manner, and the Spielberger Questionnaire was completed again. The control group received usual ward care. After the end of the study, the Spielberger anxiety questionnaire is completed again by the mothers.
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240216061027N1
Registration date:2024-03-28, 1403/01/09
Registration timing:registered_while_recruiting
Last update:2024-03-28, 1403/01/09
Update count:0
Registration date
2024-03-28, 1403/01/09
Registrant information
Name
Alireza Ghobad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5552
Email address
a.ghobad@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
عنوان طرح(انگلیسی) Investigating the effect of regular breathing on anxiety of mothers with premature infant hospitalized in the Neonatal Intensive Care Unit
Public title
Investigating the effect of regular breathing on anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1) Gestational age 26 to 36 weeks
2) They do not have the experience of admitting a newborn or premature baby in the neonatal intensive care unit, regardless of the birth order of the baby
3) Don't have any significant crises in the last six months (loss of parents, divorce)
4) Babies should be hospitalized in the intensive care unit for at least three days
5) People who want to participate in the study
6) Parents should not participate in any other intervention program on anxiety during the study
Exclusion criteria:
The baby has a recognizable abnormality that increases the mother's anxiety
Taking anti-anxiety and anti-depressant drugs
Working mothers in healthcare and medical science environments
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In order to prevent the exchange of information between the intervention and control groups, a time block is used. First, sampling is done from the control group and then the intervention, and then the questionnaires are completed by the control group, and after the number of samples in the control group is completed, sampling is stopped for 3 weeks so that the parents of the participants in the control group are discharged. become After that, the sampling of the intervention group will be started in the mentioned way. In each group, from the first day of sampling, the statistical consultant has provided us with a number of random numbers based on the people who are accepted from the first day, using the Random Allocation software. Sampling is done from people who meet the entry criteria.
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 Yazd University of Medical Sciences
Street address
Shahid Sadoughi Blvd., Ba Honar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2024-01-03, 1402/10/13
Ethics committee reference number
IR.SSU.REC.1402.100
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
The anxiety score in the Spielberger questionnaire ranges from none or the least to the most severe.
Timepoint
Spielberger anxiety questionnaire before the start of the intervention and after the end of the intervention (seven days)
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
1
Description
Anxiety score of mothers with hospitalized premature infant
Timepoint
before the start of the intervention and after the start of the intervention (seven days)
Method of measurement
Spielberger questionnaire with 40 questions
Intervention groups
1
Description
Intervention group: The intervention group is included in the study after completing the demographic information questionnaire and checking the entry criteria if eligible, and the Spielberger anxiety questionnaire is completed before the intervention. In this research, from the second or third day after the admission of the babies (fixation of the mother's physical condition), mothers are taught regular breathing until complete learning by the researcher. In this type of regular breathing, hey-hu technique is used. In this method, mothers first take a deep breath and while exhaling, they whisper hei, and they take a deep breath again and exhale by whispering ho. This work is practiced and repeated for a precise performance. The breathing rate is 16-20 times per minute for mothers. Breathing exercises by mothers every day at two specific times, once in the morning after the doctor's visit and once in the evening, each time for 20 minutes and every five minutes and each time for one minute (one minute of regular breathing and four minutes of rest) for It is done for seven days according to the method taught. After the intervention, the Spielberger anxiety level questionnaire is completed again by the mothers.
Category
Behavior
2
Description
Control group: After completing the demographic information questionnaire and checking the entry criteria, the control group entered the study and completed the Spielberger anxiety questionnaire. The control group received usual ward care. After the end of the study, the Spielberger anxiety questionnaire is completed again by the mothers.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Zahra pour Movahed
Street address
Shahid Sadouqi Hospital, Ibn Sina Boulevard, Shahid Kandi Boulevard, Yazd city, Yazd province
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
Movahed446@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargoui
Street address
Central building of Yazd University of Medical Sciences, Bahnar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Alireza Ghobad
Position
Master's student in neonatal nursing
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Shahid Faqihi Hospital, Zand Boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3232 5552
Email
Ali25ghobad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alireza Ghobad
Position
Senior student of neonatal nursing
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Shahid Faqihi Hospital, Zand Boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۶۱۱۴
Phone
+98 71 3232 5552
Email
Ali25ghobad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alireza Ghobad
Position
Senior student of neonatal nursing
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Shahid Faqihi Hospital, Zand Boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۶۱۱۴
Phone
+98 71 3232 5552
Email
Ali25ghobad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The main results of this study are sharing and it is not possible to identify people due to the confidentiality of their personal information before sharing
When the data will become available and for how long
Time period of 3 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Do not make unauthorized and personal use of the data
They are only allowed to publish scientific results
From where data/document is obtainable
To the email address Ali25ghobad@gmail.com
Contact number 09338903314
or refer to Mrs. Doktorpour Mohed's office at the address of the Faculty of Nursing in Yazd.
What processes are involved for a request to access data/document
Request by email
or in person
Duration of one week