Effects of Benson Relaxation Exercise on Anxiety Level and Sleep Quality in Adolescents (BRE)

December 24, 2024 updated by: Aydan Akkurt Yalçıntürk, Uskudar University

The Effect of Benson Relaxation Exercise on Anxiety Level and Sleep Quality in Adolescents Receiving Inpatient Treatment in a Psychiatric Clinic: A Randomized Controlled Trial

Purpose: The purpose of this study is to examine the effects of Benson relaxation exercise applied to children and adolescents receiving inpatient treatment in a psychiatric clinic on anxiety levels and sleep quality.

Design: The study is a randomized controlled trial with a pretest-posttest control group.

Method: The study will be conducted in a private psychiatric hospital in Turkey between October 2024 and June 2025. When hospital records were examined, it was determined that 100 patients received inpatient treatment in the last year. Therefore, the universe of the study consisted of 100 patients. The effect of some instructions in the Benson relaxation exercise on delusions and hallucinations is unknown. Therefore, psychosis and schizophrenia patients with delusions and hallucinations will be excluded from the scope of the study. Patients who meet the inclusion criteria will be randomly assigned to the intervention and control groups. The study will be terminated when a total of 60 patients are reached, 30 in the intervention and 30 in the control group. Benson relaxation exercise will be applied to the patients in the intervention group. No application will be made to the patients in the control group. Research data will be collected with the "State-Trait Anxiety Scale" and "Pittsburgh Sleep Quality Index".

Hypotheses:

H1: The anxiety level of patients who applied Benson relaxation exercise is lower than the patients who did not.

H2: The sleep quality of patients who applied Benson relaxation exercise is better than the patients who did not.

Study Overview

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

    • Istanbul
      • Ümraniye, Istanbul, Turkey, 34010
        • Uskudar 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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being treated in the child and adolescent clinic at the hospital where the study was conducted
  • Being between the ages of 14-18
  • Not diagnosed with psychotic disorder or schizophrenia
  • Scoring between 20 and 59 on the STAI I-II scale
  • Scoring 5 and above on the PSQI scale
  • Being willing to participate in the study
  • Parents giving verbal consent for participation in the study and signing the written voluntary consent form

Exclusion Criteria:

  • Not receiving treatment in the child-adolescent clinic at the hospital where the study was conducted
  • Not being between the ages of 14-18
  • Being diagnosed with psychotic disorder and schizophrenia
  • Not receiving a score between 20-59 on the STAI I-II scale
  • Receiving a score below 5 on the PSQI scale
  • Not being willing to participate in the study
  • The parent not giving verbal consent for participation in the study and not signing the written voluntary consent form

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
In addition to their medical treatment and care in the clinics, patients participate in activities such as group activities, leisure time and walking.
Experimental: BRE
Benson relaxation exercise is based on the patient relaxing their body muscles by focusing on deep breathing and a word that means something to them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Level
Time Frame: Ten days
State-Trait Anxiety Inventory- STAI I-II. The scale measures anxiety in both healthy and clinical populations. The scale consists of two parts: State Anxiety Inventory (STAI I) and Trait Anxiety Inventory (STAI II). STAI I determines how an individual feels at a certain time and under certain conditions, while STAI II determines how an individual feels regardless of the situation and conditions they are in. Each scale consists of two types of expressions with 20 items. Responses in STAI I and II were assessed on a 4-point scale (not at all, a little, a lot, completely). The total score obtained from both scales ranges from 20 to 80. It has also been shown that people who score higher on STAI scales are more likely to experience anxiety. The Alpha reliability coefficient of the scale was determined to be between 0.94-0.96 for STAI I and 0.83-0.87 for STAI II.
Ten days
Sleep Quality
Time Frame: Ten days
Pittsburgh Sleep Quality Index -PSQI: It provides a quantitative measure of sleep quality that is used to define good and bad sleep. PSQI contains a total of 24 questions. 19 of these questions are self-assessment questions. 5 questions are answered by the individual's spouse or a friend. These 5 questions are used only for clinical information and are not included in the evaluation. Self-assessment questions include various factors related to sleep quality. These determine sleep duration, sleep latency (time it takes to fall asleep), and frequency and severity of specific sleep-related problems. The 18 items scored are evaluated with a score between 0 and 3. The sum of the seven component scores gives the total PSQI score. The total score has a value between 0 and 21. A high total scale score indicates poor sleep quality. In the validity and reliability study of the scale, Cronbach's alpha reliability coefficient was found to be 0.80.
Ten days

Collaborators and Investigators

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

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 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 24, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61351342/020-423

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

product manufactured in and exported from the U.S.

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.

Subscribe