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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Izmir, Turkey
        • Recruiting
        • Ege University Faculty of Health Sciences Midwifery Department
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: progressive relaxation exercise group
intervention group with progressive relaxation exercise
Other: 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.
Other: relaxation background music
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.
Other: control group
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
Other: 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.
Other: relaxation background music
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.
Other: control group
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
Other: 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.
Other: relaxation background music
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.
Other: control group
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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