Benson Relaxation Technique and Stress in Pregnancy

March 27, 2025 updated by: Sümeyye BAL, Ondokuz Mayıs University

''Investigation of the Effect of Benson Relaxation Technique Applied to Pregnant Women on Fear of Childbirth, Anxiety and Stress Levels of Pregnant Women''

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Hypotheses ; H0-1: Benson relaxation technique applied to pregnant women has an effect on childbirth.

H1-1: Benson relaxation technique applied to pregnant women has no effect on childbirth.

H0-2: Benson relaxation technique applied to pregnant women has no effect on anxiety.

H1-2: Benson relaxation technique applied to pregnant women has an effect on anxiety.

H0-3: Benson relaxation technique applied to pregnant women and their partners has no effect on stress.

H1-3: Benson relaxation technique applied to pregnant women and their partners has an effect on stress The study will be conducted on two different groups. The application will be a 1-hour Benson relaxation technique applied to pregnant women in the third trimester every week for 4 weeks. Participants will be asked to do relaxation exercises twice a day, morning and evening, for 10 to 15 minutes for 1 month. A phone number that patients can call with questions will also be provided. In addition, the researcher will call the women in the intervention group every week to follow up on the relaxation process and answer questions.

After the women are evaluated in terms of eligibility criteria for the study, information about the study will be provided to the women who are eligible and written informed consent will be obtained from the women who accept. The random distribution of the women to the study groups will be carried out using the Block Randomization method. The following applications will be applied to the groups.

The researcher will contact the experimental group by phone. The application will end after 4 weeks.

Study Type

Interventional

Enrollment (Estimated)

60

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

Study Locations

  • Turkey
      • Samsun, Turkey, 55200
        • Ondokuz Mayis University

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:

  • 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

Exclusion Criteria:

  • 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

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
Experimental: relaxation group

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
Women in the 3rd trimester will receive routine care only.
Other Names:
  • control group
No Intervention: control group
**"Routine nursing care will be provided."**

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1.Change in anxiety
Time Frame: immediately intervention 4 weeks later
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

Collaborators and Investigators

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

Sponsor

Ondokuz Mayıs University

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)

June 15, 2025

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-930

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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