Progressive Relaxation ExercisesNCT06095869
Progressive Relaxation Exercises,Breastfeeding
A study testing progressive relaxation exercise and relaxation background music in people with Progressive Relaxation Exercises, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
OBJECTIVE: The research was conducted to examine the effects of progressive relaxation exercises on mothers' breastfeeding status, self-efficacy and maternal attachment level. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Progressive Relaxation Exercises
- What is being tested?
- progressive relaxation exercise and relaxation background music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- Practicing relaxation exercises before
- Mothers using chronic opioids, antidepressants and psychoactive drugs.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University Faculty of Health Sciences Midwifery Department
Izmir
çiğdem gök, 05446293395, akinakinanadolu_u@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Progressive Relaxation Exercises
- Being tested
- progressive relaxation exercise, relaxation background music, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exerciseOther
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.
relaxation background musicOther
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.
control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| progressive relaxation exercise group | Experimental | intervention group with progressive relaxation exercise Receives: Other: progressive relaxation exercise; Other: relaxation background music; Other: control group |
| relaxation background music group | Experimental | intervention group with relaxation background music Receives: Other: progressive relaxation exercise; Other: relaxation background music; Other: control group |
| control group | Experimental | group receiving routine health protocol and no intervention Receives: Other: progressive relaxation exercise; Other: relaxation background music; Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breastfeeding self-efficacy score averages change in breastfeeding self-efficacy scores
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.
Measured: in the first two weeks postpartum, in the 1st and 2nd months after birth
Secondary outcomes (1)
change in maternal attachment score averages
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.
Measured: postpartum 1st month and 2nd months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 May 2022
- Primary completion4 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Relaxation ExercisesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, çigdem gök, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095869
- Sponsor's protocol ID
- EGE-C-GOK-001
- Status last verified
- Oct 2023
- First submitted
- 15 Jun 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ege University Faculty of Health Sciences Midwifery Department
- ClinicalTrials.gov ID
- NCT06095869
- Acronym / sponsor ID
- EGE-C-GOK-001
- Conditions
- Progressive Relaxation Exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 4 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVE: The research was conducted to examine the effects of progressive relaxation exercises on mothers' breastfeeding status, self-efficacy and maternal attachment level.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| progressive relaxation exercise group | Experimental | Other: progressive relaxation exercise, Other: relaxation background music, Other: control groupintervention group with progressive relaxation exercise |
| relaxation background music group | Experimental | Other: progressive relaxation exercise, Other: relaxation background music, Other: control groupintervention group with relaxation background music |
| control group | Experimental | Other: progressive relaxation exercise, Other: relaxation background music, Other: control groupgroup receiving routine health protocol and no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (2 listed)
- Practicing relaxation exercises before
- Mothers using chronic opioids, antidepressants and psychoactive drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progressive relaxation exerciseBreastfeeding 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. | Other | control group, progressive relaxation exercise group, relaxation background music group |
| relaxation background musicIn 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. | Other | control group, progressive relaxation exercise group, relaxation background music group |
| control groupMothers 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. | Other | control group, progressive relaxation exercise group, relaxation background music group |
Primary outcome
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.
1 secondary outcome
change in maternal attachment score averages
Time frame: postpartum 1st month and 2nd months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive relaxation exercise and relaxation background music in people with Progressive Relaxation Exercises, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact çiğdem gök (05446293395, akinakinanadolu_u@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.