NCT05462431

Brief Summary

Pregnancy is a natural but complex period in a woman's life that requires a process of adaptation to physiological, psychological and social changes. The woman first goes through a process of adaptation to pregnancy and then to motherhood. Deep Relaxation exercises, which is a low-cost and non-pharmacological method, can be effective in supporting maternal-fetal attachment and improving the perception of pregnancy. A total of 80 pregnant women (40 deep relaxation excercises and 40 control) are planned to be included in the study. Data will be collected with the 'Personel Description Form', 'Maternal Antenatal Attachment Scale (MAAS)' and 'the Pregnancy Self Perception Scale'.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

May 21, 2025

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

July 14, 2022

Last Update Submit

May 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maternal Antenatal Attachment Scale (MAAS)

    The scale is likert type and each item is scored between 1-5. 11 items in the scale are scored in the opposite direction. There are two sub-dimensions in the scale.

    At the end of the 1 months

Study Arms (2)

web-based deep relaxation exercise intervention

EXPERIMENTAL
Behavioral: Deep relaxation exercises intervention

control

NO INTERVENTION

Interventions

Deep relaxation exercises intervention: breathing exercise, suitable positions for rest, and relaxation exercise instructions.

web-based deep relaxation exercise intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having internet access,
  • weeks or more of pregnancy,
  • There is no risk factor in pregnancy

You may not qualify if:

  • Mental disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cankiri Karatekin University Faculty of Health Sciences

Çankırı, Centre, 18000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr. in the Çankırı Karatekin University Midwifery Department

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 18, 2022

Study Start

August 1, 2022

Primary Completion

September 2, 2022

Study Completion

October 15, 2022

Last Updated

May 21, 2025

Record last verified: 2022-07

Locations