- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06095869
Progressive Relaxation Exercises,Breastfeeding
October 17, 2023 updated by: çigdem gök, Ege University
Ege University Faculty of Health Sciences Midwifery Department
OBJECTIVE: The research was conducted to examine the effects of progressive relaxation exercises on mothers' breastfeeding status, self-efficacy and maternal attachment level.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
may 2022 and November 2022.
The sample of the study consisted of 114 mothers who were breastfeeding in the postpartum period.
In the study, 38 breastfeeding mothers were included in the PGE, GFM and control groups.
Breastfeeding mothers in the PGE group were given a PGE application 3 days a week before going to bed and for 4 weeks, accompanied by a training CD prepared by the Turkish Psychological Association, under the supervision of the researcher.
On the other hand, the breastfeeding mothers in the GFM group were listened to the relaxation background music included in the Progressive Relaxation Exercise CD 3 days a week before going to bed and for 4 weeks.
Mothers in the control group received routine care practices applied in the clinic.
The mothers in the control group did not receive any intervention and only measurement tools were applied.
'Personal Information Form', 'Breastfeeding Self-Efficacy Scale' and 'Maternal Attachment Scale', 'Visual Analog Scale', 'Breastfeeding Classification' were used to collect data.
Standard Deviation, Mean, Frequency and Chi-square tests were used to evaluate the data.
Analysis of variance was used for repetitive measurements for the evaluation of breastfeeding self-efficacy and maternal attachment level within the group, and one-way analysis of variance was used for the evaluation between groups.
Study Type
Interventional
Enrollment (Estimated)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: çiğdem gök
- Phone Number: 05446293395
- Email: akinakinanadolu_u@hotmail.com
Study Locations
-
-
-
Izmir, Turkey
- Recruiting
- Ege University Faculty of Health Sciences Midwifery Department
-
Contact:
- çiğdem gök
- Phone Number: 05446293395
- Email: akinakinanadolu_u@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:Mothers over the age of 18,
- At least primary school graduate, able to read and understand Turkish,
- Has a phone and internet
- Has an only and healthy baby,
- Does not have a condition that prevents him from doing PGE,
- The baby was born between 2500-4000 g,
- Those who live within the provincial borders of Uşak,
- No hearing problem,
- Mothers of babies who do not have sucking problems (cleft palate-lip, frenilium, galactosemia, prematurity),
- Mothers who do not have any health problems affecting breastfeeding (mastitis, breast abscess, nipple crack, candida albicans, flat and sunken nipples, Wilson's disease in the mother, an active disease of the mother that prevents breastfeeding, and drug use),
- Mothers without musculoskeletal disorders, The mothers who volunteered to participate in the study.
Exclusion Criteria:
- Practicing relaxation exercises before
- Mothers using chronic opioids, antidepressants and psychoactive drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: progressive relaxation exercise group
intervention group with progressive relaxation exercise
|
Breastfeeding mothers in the progressive relaxation exercise group were applied gradual relaxation exercise before going to bed 3 days a week and for 4 weeks, under the supervision of the researcher, accompanied by a training CD prepared by the Turkish Psychologists Association.
In the relaxation background music group, breastfeeding mothers were listened to relaxation background music on the Progressive Relaxation Exercise CD before going to bed 3 days a week and for 4 weeks.
Mothers in this group received routine care practices in the clinic.
No intervention was made to the mothers in the control group, only data collection tools were applied.
|
|
Experimental: relaxation background music group
intervention group with relaxation background music
|
Breastfeeding mothers in the progressive relaxation exercise group were applied gradual relaxation exercise before going to bed 3 days a week and for 4 weeks, under the supervision of the researcher, accompanied by a training CD prepared by the Turkish Psychologists Association.
In the relaxation background music group, breastfeeding mothers were listened to relaxation background music on the Progressive Relaxation Exercise CD before going to bed 3 days a week and for 4 weeks.
Mothers in this group received routine care practices in the clinic.
No intervention was made to the mothers in the control group, only data collection tools were applied.
|
|
Experimental: control group
group receiving routine health protocol and no intervention
|
Breastfeeding mothers in the progressive relaxation exercise group were applied gradual relaxation exercise before going to bed 3 days a week and for 4 weeks, under the supervision of the researcher, accompanied by a training CD prepared by the Turkish Psychologists Association.
In the relaxation background music group, breastfeeding mothers were listened to relaxation background music on the Progressive Relaxation Exercise CD before going to bed 3 days a week and for 4 weeks.
Mothers in this group received routine care practices in the clinic.
No intervention was made to the mothers in the control group, only data collection tools were applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in breastfeeding self-efficacy score averages change in breastfeeding self-efficacy scores
Time Frame: in the first two weeks postpartum, in the 1st and 2nd months after birth
|
To determine the breastfeeding self-efficacy score averages, the breastfeeding self-efficacy scale average scores were compared, and the breastfeeding self-efficacy scale was applied to the mothers.The scale assessing breastfeeding self-efficacy is a 5-point Likert type (1 = Not at all sure, 2 = Very unsure, 3 = Sometimes sure, 4 = Sure, 5 = Very sure).
All items of the scale have a positive meaning.
The highest score that can be obtained from the scale is 70 and the lowest score is 14.
The scale has no cut-off point.
Increasing scores on the scale indicate high breastfeeding self-efficacy.
|
in the first two weeks postpartum, in the 1st and 2nd months after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in maternal attachment score averages
Time Frame: postpartum 1st month and 2nd months after birth
|
To determine the maternal attachment mean scores, the maternal attachment mean scores were compared and the maternal attachment scale was applied to the mothers.Each item ranges from "always" to "never" and is a 4-point Likert-type scale.
It is calculated as always (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d) = 1 point, and each item contains direct expressions.
The lowest score obtained from the scale varies between 26 and the highest score 104.
The higher the score obtained from the scale, the higher the maternal attachment is considered to be.
|
postpartum 1st month and 2nd months after birth
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in breastfeeding status
Time Frame: in the first two weeks postpartum, in the 1st and 2nd months after birth
|
To evaluate the breastfeeding status of mothers, a form evaluating the breastfeeding status prepared by the World Health Organization in 1991 was used.
|
in the first two weeks postpartum, in the 1st and 2nd months after birth
|
|
satisfaction rating
Time Frame: postpartum 4th month
|
A satisfaction scale was applied to evaluate the satisfaction of mothers with the interventions applied.This form, prepared by the researcher within the scope of the literature; It consists of five questions that evaluate how effective the application is for mothers in the PGE and GFM groups, how satisfied they are with the application, and whether they would recommend it to other mothers.
|
postpartum 4th month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Estimated)
November 4, 2023
Study Completion (Estimated)
November 30, 2023
Study Registration Dates
First Submitted
June 15, 2023
First Submitted That Met QC Criteria
October 17, 2023
First Posted (Actual)
October 23, 2023
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- EGE-C-GOK-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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