Online Web-Based Deep Relaxation Exercise Applied to Pregnant Women on Maternal Fetal Attachment and Pregnancy Perception

December 5, 2024 updated by: Nilay Gökbulut, Çankırı Karatekin University

The Effect of Online Web-Based Deep Relaxation Exercise Applied to Pregnant Women on Maternal Fetal Attachment and Pregnancy Perception: A Randomized Controlled Trial

This study was planned as a pre-test post-test randomized controlled study in order to determine the effects of an online web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment and pregnancy perception. The study is planned to be conducted with pregnant women reached through social media (such as Facebook, Messenger, Instagram). The study is planned to be conducted between December 15, 2024 and June 15, 2025. The universe of the study will consist of pregnant women who volunteer to participate in online deep relaxation exercises and share their contact information. When the power analysis was performed, the sample size was calculated as a total of 80 pregnant women (40 experimental, 40 control), assuming that the web-based deep relaxation exercise applied would increase the mean maternal-fetal attachment score (72.25±7.16) (Güney and Uçar, 2019) by four and a half points at a 5% error level, a two-sided significance level, a 95% confidence interval, and an 80% ability to represent the universe (https://www.stat.ubc.ca/~rollin/stats/ssize/n2.html). Pregnant women to be included in the groups will be selected from the relevant population using the improbable random sampling method.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

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 Contact

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women with internet access,
  • Women expecting a single baby,
  • Women whose pregnancy is 12-24 weeks

Exclusion Criteria:

  • Women with a history of physical and/or psychological illness and those taking any psychiatric medication
  • Women who answered the survey questions incompletely.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Experimental: Web-based deep relaxation exercise
Other: Web-Based Deep Relaxation Exercise
Web-based deep relaxation exercise videos have been prepared online. Each video lasts approximately 20-25 minutes. The 4-week applications will be sent to pregnant women one video each week and they will be asked to continue the exercises at home 4 times a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of online web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment
Time Frame: Four months
Four months

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of online web-based deep relaxation exercise applied to pregnant women on pregnancy perception
Time Frame: Four months
Four months

Collaborators and Investigators

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

Sponsor

Çankırı Karatekin University

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

Helpful Links

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 (Estimated)

December 15, 2024

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • KARATEKIN UNIVERSITY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared, because before starting the research, pregnant women who will participate in the research, as they will be guaranteed that their personal information will be kept completely confidential and will only be used for this research purpose.

Study Data/Documents

  1. Individual Participant Data Set

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.

Clinical Trials on Maternal Fetal Attachment Pregnancy Perception

Clinical Trials on Web-Based Deep Relaxation Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe