NCT05453734

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

June 22, 2022

Last Update Submit

July 11, 2022

Conditions

Keywords

motherself efficacypostpartum depressionpreterm infantprogressive muscle relaxation

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Self-Efficacy Scale Score (BSES)

    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 Outcomes (3)

  • Edinburgh Postpartum Depression Scale Score (EDPS)

    At the end of the 1st and 2nd week of the intervention

  • Edinburgh Postpartum Depression Scale (EDPS) Scores Change in Experimental and Control Group

    At the end of the 2nd week of follow-up

  • Edinburgh Postpartum Depression Scale Scores Differences (EDPS) of the Groups

    At the end of the 2nd week of follow-up

Study Arms (2)

Experimental Group: The group applied Progressive Muscle Relaxation Exercises

EXPERIMENTAL

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

Control group: The group without any ıntervention

NO INTERVENTION

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.

Interventions

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

Experimental Group: The group applied Progressive Muscle Relaxation Exercises

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kadriye Şahin

Istanbul, Şişli, 34360, Turkey (Türkiye)

Location

Related Publications (20)

  • Ionio C, Colombo C, Brazzoduro V, Mascheroni E, Confalonieri E, Castoldi F, Lista G. Mothers and Fathers in NICU: The Impact of Preterm Birth on Parental Distress. Eur J Psychol. 2016 Nov 18;12(4):604-621. doi: 10.5964/ejop.v12i4.1093. eCollection 2016 Nov.

    PMID: 27872669BACKGROUND
  • Miles MS, Funk SG, Kasper MA. The stress response of mothers and fathers of preterm infants. Res Nurs Health. 1992 Aug;15(4):261-9. doi: 10.1002/nur.4770150405.

    PMID: 1496151BACKGROUND
  • Howe TH, Sheu CF, Wang TN, Hsu YW. Parenting stress in families with very low birth weight preterm infants in early infancy. Res Dev Disabil. 2014 Jul;35(7):1748-56. doi: 10.1016/j.ridd.2014.02.015. Epub 2014 Mar 19.

    PMID: 24656293BACKGROUND
  • Holditch-Davis D, Santos H, Levy J, White-Traut R, O'Shea TM, Geraldo V, David R. Patterns of psychological distress in mothers of preterm infants. Infant Behav Dev. 2015 Nov;41:154-63. doi: 10.1016/j.infbeh.2015.10.004. Epub 2015 Oct 22.

    PMID: 26495909BACKGROUND
  • Henderson J, Carson C, Redshaw M. Impact of preterm birth on maternal well-being and women's perceptions of their baby: a population-based survey. BMJ Open. 2016 Oct 8;6(10):e012676. doi: 10.1136/bmjopen-2016-012676.

    PMID: 27855105BACKGROUND
  • Vigod SN, Villegas L, Dennis CL, Ross LE. Prevalence and risk factors for postpartum depression among women with preterm and low-birth-weight infants: a systematic review. BJOG. 2010 Apr;117(5):540-50. doi: 10.1111/j.1471-0528.2009.02493.x. Epub 2010 Jan 29.

    PMID: 20121831BACKGROUND
  • Ranger A, Helmert E, Bott TS, Ostermann T, Als H, Bassler D, Hautzinger M, Vagedes J. Physiological and emotional effects of pentatonic live music played for preterm neonates and their mothers in the Newborn Intensive Care Unit: A randomized controlled trial. Complement Ther Med. 2018 Dec;41:240-246. doi: 10.1016/j.ctim.2018.07.009. Epub 2018 Aug 1.

    PMID: 30477847BACKGROUND
  • Glover V. Prenatal stress and its effects on the fetus and the child: possible underlying biological mechanisms. Adv Neurobiol. 2015;10:269-83. doi: 10.1007/978-1-4939-1372-5_13.

    PMID: 25287545BACKGROUND
  • Simpson M, Schmied V, Dickson C, Dahlen HG. Postnatal post-traumatic stress: An integrative review. Women Birth. 2018 Oct;31(5):367-379. doi: 10.1016/j.wombi.2017.12.003. Epub 2018 Jan 11.

    PMID: 29337007BACKGROUND
  • Sharmin KN, Sarwar N, Mumu SJ, Taleb DA, Flora MS. Postnatal depression and infant growth in an urban area of Bangladesh. Midwifery. 2019 Jul;74:57-67. doi: 10.1016/j.midw.2019.03.014. Epub 2019 Mar 22.

    PMID: 30927633BACKGROUND
  • Dennis CL. Identifying predictors of breastfeeding self-efficacy in the immediate postpartum period. Res Nurs Health. 2006 Aug;29(4):256-68. doi: 10.1002/nur.20140.

    PMID: 16847899BACKGROUND
  • Chuang LL, Lin LC, Cheng PJ, Chen CH, Wu SC, Chang CL. Effects of a relaxation training programme on immediate and prolonged stress responses in women with preterm labour. J Adv Nurs. 2012 Jan;68(1):170-80. doi: 10.1111/j.1365-2648.2011.05765.x. Epub 2011 Jul 20.

    PMID: 21771042BACKGROUND
  • Zubaran C, Foresti K. The correlation between breastfeeding self-efficacy and maternal postpartum depression in southern Brazil. Sex Reprod Healthc. 2013 Mar;4(1):9-15. doi: 10.1016/j.srhc.2012.12.001. Epub 2012 Dec 20.

    PMID: 23427927BACKGROUND
  • Özcan N, Karagözoğlu Ş. Effects of progressive muscle relaxation exercise, cold application and local anesthesia performed before chest tube removal on pain and comfort levels and vital sings of the patient. Turkiye Klin J Med Sci. 2020;40(3):285-96.

    BACKGROUND
  • Engindeniz A, Küey L, Kültür S. Turkish form of Edinburgh postpartum depression scale validity and reliability study. In: Bahar Sempozyumları 1 Kitabı [Internet]. Ankara: Publications of the Psychiatric Association; 1996 [cited 2022 Feb 11]. p. 51-2. Available from: https://toad.halileksi.net/olcek/edinburgh-dogum-sonrasi-depresyon-olcegi

    BACKGROUND
  • Lawrence RM, Lawrence RA. Breastfeeding: more than just good nutrition. Pediatr Rev. 2011 Jul;32(7):267-80. doi: 10.1542/pir.32-7-267. No abstract available.

    PMID: 21724901BACKGROUND
  • Alus Tokat M, Okumus H, Dennis CL. Translation and psychometric assessment of the Breast-feeding Self-Efficacy Scale-Short Form among pregnant and postnatal women in Turkey. Midwifery. 2010 Feb;26(1):101-8. doi: 10.1016/j.midw.2008.04.002. Epub 2008 Jun 9.

    PMID: 18541350BACKGROUND
  • Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

    PMID: 3651732BACKGROUND
  • Helmer G. Progressive Muskelrelaxation nach Edmund Jacobson. In: Burnout und Stress. Springer; 2008. p. 91-110.

    BACKGROUND
  • McCallie MS, Blum CM, Hood CJ. Progressive muscle relaxation. J Hum Behav Soc Environ [Internet]. 2006 Jul 13 [cited 2022 Feb 11];13(3):51-66. Available from: /record/2007-02269-004

    BACKGROUND

MeSH Terms

Conditions

Premature BirthDepression, Postpartum

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Birsen Mutlu, Ph.d

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant in the Department of Child Health and Diseases Nursing

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 12, 2022

Study Start

November 20, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 12, 2022

Record last verified: 2022-07

Locations