Relaxation ProgramBRENCT06661304
Effects of Benson Relaxation Exercise on Anxiety Level and Sleep Quality in Adolescents
A study testing Benson Relaxation Exercise and Ongoing treatment in people with Relaxation Program and Anxiety, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Relaxation Program, Anxiety, Sleep Quality
- What is being tested?
- Benson Relaxation Exercise and Ongoing treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Being tested
- Benson Relaxation Exercise, Ongoing treatment
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benson Relaxation ExerciseOther
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.
Ongoing treatmentOther
In addition to their medical treatment and care in the clinics, patients participate in activities such as group activities, leisure time and walking.
| Study group | Role | What they receive |
|---|---|---|
| BRE | Experimental | Not described Receives: Other: Benson Relaxation Exercise |
| Control | Active comparator | Not described Receives: Other: Ongoing treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study startDec 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relaxation ProgramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydan Akkurt Yalçıntürk, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661304
- Sponsor's protocol ID
- 61351342/020-423
- Acronym
- BRE
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06661304
- Acronym / sponsor ID
- BRE / 61351342/020-423
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRE | Experimental | Other: Benson Relaxation Exercise |
| Control | Active comparator | Other: Ongoing treatment |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benson Relaxation ExerciseBenson relaxation exercise is based on the patient relaxing their body muscles by focusing on deep breathing and a word that means something to them. | Other | BRE |
| Ongoing treatmentIn addition to their medical treatment and care in the clinics, patients participate in activities such as group activities, leisure time and walking. | Other | Control |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benson Relaxation Exercise and Ongoing treatment in people with Relaxation Program and Anxiety, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aydan Akkurt Yalçıntürk (+905321392497, aydan.akkurtyalcinturk@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Level (time frame: Ten days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.