Effects of Benson Relaxation Exercise on Anxiety Level and Sleep Quality in Adolescents (NCT06661304) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Benson Relaxation Exercise on Anxiety Level and Sleep Quality in Adolescents
Turkey (Türkiye)60 participantsStarted 2024-12
Plain-language 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.
Who can participate
Age range
14 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.