NCT06870214

Brief Summary

The aim of this study is to determine the effect of the Benson Relaxation Technique applied to pregnant women on their fear of birth, anxiety and stress levels.

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
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

March 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 5, 2025

Last Update Submit

March 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1.Change in anxiety

    Beck Anxiety Inventory scale (BAI). The BAI measures only the frequency of anxiety symptoms in detail. It is a Likert-type self-assessment scale comprised of 21 items scored between 0 and 3. The higher the total score, the higher the anxiety experienced by the person (minimal: 0-7, mild: 8-15, moderate:16-25, and severe: 26-63 points). 18 The Turkish validity and reliability of the BSI has been reported by Ulusoy et al.

    immediately intervention 4 weeks later

Study Arms (2)

relaxation group

EXPERIMENTAL

They will be interviewed according to the inclusion criteria and exclusion criteria, and they will be informed about the study and their consent will be obtained, the participant information form and depression form will be filled, a pre-test will be performed and the communication will be completed. Their numbers will be taken. The intervention group will be given a 1-hour Benson relaxation technique every week for 4 weeks. Participants will be asked to do relaxation exercises for 10 to 15 minutes twice a day, in the morning and evening, for 1 month. A phone number will be provided for patients to call if they have questions. In addition, the researcher will call the women in the intervention group every week to follow up on the relaxation process and answer questions. The researcher will contact the experimental group by phone. He/she will introduce himself/herself and final tests will be conducted after 4 weeks.

Other: relaxation

control group

NO INTERVENTION

\*\*"Routine nursing care will be provided."\*\*

Interventions

Women in the 3rd trimester will receive routine care only.

Also known as: control group
relaxation group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Those who are in their 28th-38th weeks of pregnancy,
  • People with mental illness,
  • People who have Anxiety disorder,
  • People with hearing loss;
  • People who have no experience of using relaxation methods in the past,
  • People who have not used herbal or medical sedatives

You may not qualify if:

  • Those who do not want to participate in the intervention,
  • Those who have a termination of pregnancy during the intervention,
  • Those who have a risky pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Sümeyye BAL, Ph.D

CONTACT

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
Lecturer Ph. D.

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 11, 2025

Study Start

June 15, 2025

Primary Completion

October 15, 2025

Study Completion

October 30, 2025

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations