NCT06746584

Brief Summary

This study was planned to investigate the effect of Benson Relaxation Exercise on anxiety and sleep quality in inpatients in psychiatric ward. The following hypothesis will be tested in the study. H1: Anxiety level of the patients who underwent Benson relaxation exercise is lower than the patients who did not undergo Benson relaxation exercise. H2: The sleep quality of patients who undergo Benson relaxation exercise is better than patients who do not undergo Benson relaxation exercise. The study is designed as a single-blind, randomised controlled trial. The study will be conducted in four psychiatric wards of a private psychiatric hospital in Turkey between 18.11.2024-06.06.2025. Verbal and written informed consent will be obtained from participants or their legal guardians before assignment to study groups. The study will be conducted according to the CONSORT flow diagram (http://www.consort-statement.org/consort-statement/flow-diagram) (2010)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

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

November 29, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

December 23, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2025

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

November 29, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

psychiatric inpatients, Benson relaxation, sleep Quality, anxiety

Outcome Measures

Primary Outcomes (1)

  • anxiety level -STAI Forms

    anxiety level, the STAI-II forms

    up to 6 months

Secondary Outcomes (1)

  • Sleep quality-Pittsburg Sleep Quality Index (PSQI)

    up to 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Since patients diagnosed with psychotic disorder and schizophrenia have delusions and hallucinations, the effect of some instructions in the Benson relaxation technique on these symptoms cannot be known. Therefore, it was planned to exclude psychosis and schizophrenia patients with delusions and hallucinations from the study.

Behavioral: benson relaxation exercise

Control Group

NO INTERVENTION

Since patients diagnosed with psychotic disorder and schizophrenia have delusions and hallucinations, the effect of some instructions in the Benson relaxation technique on these symptoms cannot be known. Therefore, it was planned to exclude psychosis and schizophrenia patients with delusions and hallucinations from the study

Interventions

BRT is one of the behavioural intervention techniques developed by Herbert Benson in 1975. BRT is based on the principle of deep breathing and relaxing all the muscles in the body by choosing a word that is meaningful for the individual and focusing on it. This exercise, which has no side effects on patients and can be applied for patients of all age groups, is more widely used because it is a simple and easy-to-learn method compared to other relaxation methods all the muscles in the body by choosing a word that is meaningful for the individual and focusing on it.

Also known as: benson relaxation
Intervention Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years and over,
  • patients being treated for mood, anxiety, obsessive-compulsive disorder and substance use disorder,
  • patients with STAI I-II scores between 20 and 59, patients with PSQI score above 5.

You may not qualify if:

  • Patients under 18 years of age,
  • patients with psychotic disorders with hallucinations and delusions, patients with schizophrenia,
  • patients with STAI I-II score below 20 and above 59, patients with PSQI score below 5.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: randomized controlled trial single blinded
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Dr. (Psychiatric Nursing)

Study Record Dates

First Submitted

November 29, 2024

First Posted

December 24, 2024

Study Start

December 23, 2024

Primary Completion

June 2, 2025

Study Completion

December 2, 2025

Last Updated

December 24, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share