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

NCT06661304 | Not Yet Recruiting

• 1 other identifier: 61351342/020-423
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relaxation Program; Anxiety; Sleep Quality; Psychiatric Hospitalization

Outcome Measures

Primary Outcomes (2)

• Anxiety Level

  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

  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

Study Arms (2)

BRE

EXPERIMENTAL

Other: Benson Relaxation Exercise

Control

ACTIVE COMPARATOR

Other: Ongoing treatment

Interventions

Benson Relaxation Exercise OTHER

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.

BRE

Ongoing treatment OTHER

In addition to their medical treatment and care in the clinics, patients participate in activities such as group activities, leisure time and walking.

Control

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Uskudar University

Ümraniye, Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Aydan Akkurt Yalçıntürk

CONTACT

+905321392497; aydan.akkurtyalcinturk@uskudar.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: December 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)