NCT06095869

Brief Summary

OBJECTIVE: The research was conducted to examine the effects of progressive relaxation exercises on mothers' breastfeeding status, self-efficacy and maternal attachment level.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2023

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

June 15, 2023

Last Update Submit

October 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    in the first two weeks postpartum, in the 1st and 2nd months after birth

Secondary Outcomes (1)

  • change in maternal attachment score averages

    postpartum 1st month and 2nd months after birth

Other Outcomes (2)

  • change in breastfeeding status

    in the first two weeks postpartum, in the 1st and 2nd months after birth

  • satisfaction rating

    postpartum 4th month

Study Arms (3)

progressive relaxation exercise group

EXPERIMENTAL

intervention group with progressive relaxation exercise

Other: progressive relaxation exerciseOther: relaxation background musicOther: control group

relaxation background music group

EXPERIMENTAL

intervention group with relaxation background music

Other: progressive relaxation exerciseOther: relaxation background musicOther: control group

control group

EXPERIMENTAL

group receiving routine health protocol and no intervention

Other: progressive relaxation exerciseOther: relaxation background musicOther: control group

Interventions

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.

control groupprogressive relaxation exercise grouprelaxation background music group

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 groupprogressive relaxation exercise grouprelaxation background music 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.

control groupprogressive relaxation exercise grouprelaxation background music group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Practicing relaxation exercises before
  • Mothers using chronic opioids, antidepressants and psychoactive drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Health Sciences Midwifery Department

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist midwife

Study Record Dates

First Submitted

June 15, 2023

First Posted

October 23, 2023

Study Start

May 1, 2022

Primary Completion

November 4, 2023

Study Completion

November 30, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations