The Effect of Progressive Muscle Relaxation Exercises

July 11, 2022 updated by: Kadriye Sahin, Istanbul University - Cerrahpasa (IUC)

The Effect of Progressive Muscle Relaxation Exercises on Breastfeeding Self-Efficacy and Depression Level of Mothers With Preterm Infants: A Randomized Controlled Study

Purpose This study was carried out to examine the effectiveness of Progressive Muscle Relaxation (PMR) exercises on mothers' breastfeeding self-efficacy and depression level with preterm infants.

Methods This study was conducted in a randomized controlled experimental design. The sample of the study consisted of 70 mothers with 32-36 weeks preterm infants (35/35 in experimental/control group) and hospitalized in the Neonatal Intensive Care Unit (NICU) of the university hospital in which the study was conducted. Introductory information form; Breastfeeding Self-Efficacy Scale (BSES), Edinburgh Postpartum Depression Scale (EPDS), and patient follow-up form were used to collect data. Progressive Muscle Relaxation (PMR) exercises were practiced on the mothers in the experimental group. The mothers were given training and instructions about the exercises. They were applied in the morning and evening for 2 weeks by the instructions. The BSES and EPDS score of both groups were evaluated in the 1st and 2nd-week follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With preterm birth, some medical and neurophysiological problems occur in the baby. The mother-father-infant interactions of these babies, who need more intensive care support after birth, are negatively affected by this process. The mother whose baby is in intensive care is separated from her baby and is worried for her life because her baby is underdeveloped and has frequent health problems. All these experiences may cause the mother to lose her maternal role. Therefore, mothers; They may experience a range of negative emotions such as sadness, mourning, fear, grief, disappointment, anger and helplessness, as well as significant psychological disturbances such as postpartum depression and anxiety disorders.

Therefore, appropriate interventions are necessary for early diagnosis and reduction of depression in the postpartum period. Stress-reducing practices such as PMR to be applied to the mother can reduce the mother's anxiety and depression levels, as well as increase breastfeeding self-efficacy. Decrease in depression and increase in breastfeeding self-efficacy will positively affect the mother's breastfeeding and contribute to the growth of the baby.

Participants and sample:

The universe of the study consisted of mothers with preterm infants of 32-36 weeks of gestation who were hospitalized in the NICU.

Sample selection criteria were determined as follows mother's having between 32-36 weeks preterm babies, mother's having enough milk to breastfeed, baby's not having an anomaly that prevents breastfeeding, baby's being fed with breast milk.

To determine the sample size of the study, the power analysis was performed based on a previous study. According to the G*Power analysis result (with a test power of 95% confidence and power of 95.82% for ß: 0.04, alpha: 0.05), the sample size was found to be 70. Considering the possibility of case loss, the total sample size was determined 80 (40 in the experimental group and 40 in the control).

The final number of mothers in the experimental group was 35 and 35 in the control group. As a result, 70 mothers in total were included in the analysis.

Data collecting:

Intervention:

When premature babies were admitted to the NICU, all parents were informed about intensive care settings and premature birth. PMR exercises were applied to the mothers in the experimental group by the researcher and the mothers were given training on the application of the exercises.

Procedure:

Interventions in the experimental group: Introductory information form and EPDS were completed by the mothers before the PMR exercises. PMR exercises were applied to the mothers by the researcher in the milking room (a quiet room) located on the NICU floor and they were given training on the application of the exercises. During the application, it was ensured that only the researcher and the mother were in the room. The application was continued until the mother was able to do the PMR exercises on her own. In case the mother applied the PMR exercises incompletely or incorrectly, the researcher did it to ensure that the mother performed the exercises correctly. It took about 30-45 minutes to do the exercises. After the application and training, the mother was given a guide on the steps of the PMR exercises. The mother was asked to perform the exercises twice a day, in the morning and evening, and record them on the follow-up form. The researcher's contact number was given to the mother for counseling in case she had difficulty following the steps of the PMR exercises. During the follow-ups, the mother was called by the researcher and a message was sent to ensure her continuity in the exercises. At the end of the 1st and 2nd weeks of the follow-up, BSES, EPDS and patient follow-up forms were filled when the mother came for routine controls.

Interventions in the control group: The descriptive information form, BSES and EPDS were first administered to the mothers. BSES and EPDS were applied to the mothers at the end of the 1st and 2nd weeks of follow-up. At the end of the 2nd week, mothers were told how to perform PMR exercises and instructions on PMR exercises were given.

Measurements:

Information Form:

In this form, there are 8 questions about the sociodemographic characteristics of the mother, her working status during pregnancy, the mode of delivery, her participation in the care of the baby in the hospital, the breastfeeding status of the previous baby and the support status of the mother, and the care of the baby after discharge.

Edinburgh Postpartum Depression Scale (EDPS):

It was defined by Cox et al. in 1987 and has been accepted all over the world as a tool that can be used in the recognition of postpartum depression by proving its validity and reliability in many countries, in different languages, until today. It is reported that it can be used for (one) routine screening in all women who have given birth. Validity studies were conducted in 2 separate studies in Turkey, and it is reported that when the cut-off score is 12-13, it is more sensitive in detecting people with true depressive symptoms. The Edinburgh Postpartum Depression Scale is not a diagnostic scale, it is used for symptom screening. The diagnosis needs to be confirmed by clinical examination. The Edinburgh Postpartum Depression Scale is a scale consisting of 10 questions, each of which asks the mother to report how she has felt over the past week by ticking one of four different options. The total score is calculated by giving a score between 0-3 for each item. In some items, the harshest responses are placed at the beginning, while in others they are placed at the end. The score varies between 0-30.

Postpartum Breastfeeding Self-Efficacy Scale (BSES):

It is a 33-item scale developed by Dennis and Faux in 1999 to evaluate mothers' breastfeeding self-efficacy levels. Later, in 2003, a 14-item short form of the scale was developed. The Breastfeeding Self-Efficacy Short Form is a 5-point Likert-type scale (1 = "I'm not sure at all" and 5 = "I'm always sure"). The lowest score that can be obtained from the scale is 14, and the highest score is 70. The higher the score, the higher the breastfeeding self-efficacy. The Turkish validity and reliability study of the scale was carried out by Alus Tokat and Okumuş in 2009.

Patient Follow-up Form:

It was created to track whether mothers of premature infants performing PMR did this exercise twice a day, morning and evening, for a month.

Practice and Guidelines for Progressive Muscle Relaxation (PMR) Exercises:

Before collecting data, one of the researchers received training and certification from a psychotherapist who is an expert in this field in order to be able to perform the PMR exercises. Guidelines for PMR exercises have been prepared in line with the literature and the training received by the researcher. In the guidelines, the person is asked to be in a comfortable place and position, to reach the face by following the large muscle groups gradually, starting from the feet, to tense the muscles in each step, and then to release them. It is necessary to take a deep breath after each muscle group, to stop for a while, and release it slowly.

Study Type

Interventional

Enrollment (Actual)

70

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 Locations

  • Turkey
    • Şişli
      • Istanbul, Şişli, Turkey, 34360
        • Kadriye Şahin

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mother's delivery of a premature baby between 32 weeks-36 weeks + 6 days,
  • The mother has enough milk to breastfeed
  • The mother's baby does not have an anomaly that prevents breastfeeding,
  • Feeding the mother's baby with breast milk

Exclusion Criteria:

  • Mothers with babies born outside the range of 32 weeks-36 weeks + 6 days
  • Having a baby with a congenital anomaly
  • Feeding a mother's baby with a formula other than breast milk

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group: The group applied Progressive Muscle Relaxation Exercises
Introductory information form and EPDS were completed by the mothers before the PMR exercises. PMR exercises were applied and training was given to the mothers by the researcher in the milking room (a quiet room) located on the NICU floor (approximately 40 minutes). The application was continued until the mother was able to do the PMR exercises on her own. After the application and training, the mother was given guidance on PMR. The mother was asked to perform the exercises twice a day, in the morning and evening, and record them on the follow-up form. The researcher's contact number was given to the mother for counseling in case she had difficulty following the steps of the PMR exercises. During the follow-ups, the mother was called by the researcher and a message was sent to ensure her continuity in the exercises. At the end of the 1st and 2nd weeks of the follow-up, BSES, EPDS and patient follow-up forms were filled when the mother came for routine controls.
Procedure: Progressive Muscle Relaxation Exercises
Before data collection, one of the researchers received training and certification from a psychotherapist specialist in this field to be able to apply the PMR exercises. The guidelines on the PMR exercises were prepared in line with the literature and training received by the researcher. In the guidelines, the person is asked to be in a comfortable place and position, to reach the face by following the large muscle groups gradually, starting from the feet, to tense the muscles in each step, and then to release them. It is necessary to take a deep breath after each muscle group, to stop for a while, and release it slowly
No Intervention: Control group: The group without any ıntervention
Introductory information form, the BSES, and the EPDS were initially applied to the mothers. At the end of the 1st and 2nd weeks of the follow-up, the BSES and the EPDS were applied to the mothers. At the end of the 2nd week, it was told the mothers how to practice the PMR exercises and the guideline on the PMR exercises was given to them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding Self-Efficacy Scale Score (BSES)
Time Frame: In the 2nd week of follow-up
BSES score is in the range of 14-70 points, and as the total score increases, breastfeeding self-efficacy also increases.
In the 2nd week of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edinburgh Postpartum Depression Scale Score (EDPS)
Time Frame: At the end of the 1st and 2nd week of the intervention
The total score to be taken from this scale varies between 0-30 points. As the total score obtained from the scale increases, the postpartum depression symptoms of the individual increase.
At the end of the 1st and 2nd week of the intervention
Edinburgh Postpartum Depression Scale (EDPS) Scores Change in Experimental and Control Group
Time Frame: At the end of the 2nd week of follow-up
At the end of the 2nd week of follow-up
Edinburgh Postpartum Depression Scale Scores Differences (EDPS) of the Groups
Time Frame: At the end of the 2nd week of follow-up
At the end of the 2nd week of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Birsen MUTLU, Ph.d, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 20, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHN503434

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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