The Effect of Web-Based Deep Relaxation Exercises in Preg... | NCT05462431

Studies
The Effect of Web-Based Deep Relaxation Exercises in Pregnant Women

NCT05462431

Sponsor

Çankırı Karatekin University

Status

Completed

Last Update Posted

May 21, 2025Actual

Enrollment

95Actual

Phase

Not Applicable

Conditions

Maternal-Fetal Relations

Interventions

Deep relaxation exercises intervention

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Actual

Primary Completion Date

Sep 2, 2022Actual

Completion Date

Oct 15, 2022Actual

First Submitted Date

Jul 14, 2022

First Submission Date that Met QC Criteria

Jul 14, 2022

First Posted Date

Jul 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2025

Last Update Posted Date

May 21, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nilay Gökbulut, Assist. Prof. Dr. in the Çankırı Karatekin University Midwifery Department, Çankırı Karatekin UniversityPrincipal Investigator

Lead Sponsor

Çankırı Karatekin UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

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. In this study, it was aimed to determine the effect of web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment and pregnancy perception. 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'. 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'. deep relaxation excercises wiil be appliedby midwives who are experts in their fields who are certified in these fields.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
web-based deep relaxation exercise intervention	Experimental		Behavioral: Deep relaxation exercises intervention
control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deep relaxation exercises intervention	Behavioral	Deep relaxation exercises intervention: breathing exercise, suitable positions for rest, and relaxation exercise instructions.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Mental disabilities

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cankiri Karatekin University Faculty of Health Sciences		Çankırı	Centre	18000	Turkey (Türkiye)