NCT05721625

Brief Summary

The aim of this study is to compare the effects of aerobic exercise and connective tissue massage on sleep, mother-infant attachment and psychological state in postpartum women.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

First Submitted

Initial submission to the registry

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

February 1, 2023

Last Update Submit

February 1, 2023

Conditions

Keywords

sleep, depression, massage, exercise

Outcome Measures

Primary Outcomes (1)

  • Postpartum Sleep Quality Scale

    In order to measure Postpartum Sleep Quality, Postpartum Sleep Quality Scale will be used. The scale includes 14 items. The lowest score that can be obtained from the scale is 0, and the highest score is 56. An increase in the score indicates a decrease in sleep quality.

    change from baseline at 8 weeks

Secondary Outcomes (2)

  • Mother to Infant Bonding Scale

    change from baseline at 8 weeks

  • Edinburgh Postpartum Depression Scale

    change from baseline at 8 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

The aerobic exercise program will be applied at moderate intensity 3 days a week for 8 weeks. Walking will be recommended as an aerobic exercise

Other: Aerobic exercise

Massage group

ACTIVE COMPARATOR

Connective tissue massage will be applied by the physiotherapist 3 days a week for 8 weeks. While postpartum women are in the sitting position, this massage will be applied on whole back.

Other: Connective tissue massage

Interventions

The aerobic exercise program will be applied at moderate intensity 3 days a week for 8 weeks. Walking will be recommended as an aerobic exercise

Exercise group

Connective tissue massage will be applied by the physiotherapist 3 days a week for 8 weeks. While the patients are in the sitting position, this massage will be applied on whole back.

Massage group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Postpartum 6th week-1 year
  • Between the ages of 18-45
  • Being literate

You may not qualify if:

  • Those with orthopedic, neurological, rheumatological, mental or any systemic chronic diseases
  • Those with cardiac problems that may interfere with exercise
  • Those with suspected pregnancy
  • Those with malignancy
  • Those who have infection
  • Those who do not regularly participate in the treatment program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

February 15, 2023

Primary Completion

April 15, 2023

Study Completion

February 15, 2024

Last Updated

February 10, 2023

Record last verified: 2023-02