Anxiety Disorder/Anxiety StateNCT06056284
The Effect of Progressive Relaxation Exercise and Sleep Hygiene Training on Sleep Quality and AnxietyLevel Given to Outpatients With Anxiety Disorder in Psychiatry Clinic
A study testing Progressive relaxation exercises and sleep hygiene training in people with Anxiety Disorder/Anxiety State, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of progressive relaxation exercise and sleep hygiene training on sleep quality and anxiety levels in patients diagnosed with anxiety disorder admitted to psychiatry outpatient clinic. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety Disorder/Anxiety State
- What is being tested?
- Progressive relaxation exercises and sleep hygiene training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2023to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be between the ages of 18 and 60
- Having been diagnosed with anxiety disorder at least 6 months ago
- No barriers in Turkish oral and written communication
- Volunteering to participate in the research
- Not having received progressive relaxation exercise and sleep hygiene training before
- To reside in Kızılcahamam district centre
- Not having Chronic Obstructive Pulmonary Disease (COPD), Heart Failure, asthma, Musculoskeletal System Diseases, etc. which may prevent progressive relaxation exercise
Who cannot join
- The individual has conditions that impair the ability to assess reality, such as psychosis, being in the manic phase of bipolar disorder
- Chronic Obstructive Pulmonary Disease (COPD), Heart Failure, asthma, Musculoskeletal System Diseases, etc. that may prevent progressive relaxation exercise
- The individual has participated in another progressive relaxation exercise and/or sleep hygiene training programme
- The individual is taking a psychiatric drug with a relaxant effect
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kızılcahamam State Hospital
Ankara, Kızılcahamam, 06890
Nur Eda BAL, +90 507 333 33 38, nuredabal@gmail.com
About this study
Official title: The Effect of Progressive Relaxation Exercise and Sleep Hygiene Training on Sleep Quality and AnxietyLevel Given to Outpatients With Anxiety Disorder in Psychiatry Outpatient Clinic
The aim of this study was to investigate the effect of progressive relaxation exercise and sleep hygiene training on sleep quality and anxiety levels in patients diagnosed with anxiety disorder admitted to psychiatry outpatient clinic.
Read the detailed description
The population of the study consisted of 1417 patients diagnosed with anxiety disorder who applied to the psychiatry outpatient clinic of Ankara Kızılcahamam State Hospital between December 2021 and February 2022. For the pretest-posttest control group research, the required sample size was determined as 47 using the G*Power 3.1.9.4 program with 95% power based on Cohen's d = 0.5 medium effect size alpha = 0.05. However, considering the data loss that may occur in the study, the sample size was determined as 52 when the dropout rate was determined as 10%. The age range of the research sample is 18-75 years old. Individuals who agree to participate in the study and meet the inclusion criteria will be assigned to the experimental and control groups by simple random sampling method. It is planned to include 26 patients in both the experimental and control groups. In the first week of this 8-week research program, the individuals in the experimental and control groups will be administered the Voluntary Consent Form, Personal Information Form consisting of 17 questions prepared by the researcher by reviewing the literature, Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS). Data will be collected by face-to-face interviews with the patients. Individuals in the experimental and control groups will be given an appointment for the posttest eight weeks later. In the second week, individuals in the experimental group will be given sleep hygiene training and a sleep hygiene brochure prepared in line with the literature. In addition, a compact disc (CD) prepared by the Turkish Psychological Association and a training brochure developed by the researcher in line with the progressive relaxation exercises CD, which includes the steps of progressive relaxation exercise application, will be used to teach the progressive relaxation exercise.
The first part of the CD includes a 10-minute description of deep relaxation, its purpose and information to be considered during the exercise. In the second 30-minute part, relaxation exercises are explained with the sound of a stream and verbal instructions. The last 30-minute section included only relaxation music without audio instructions. Before the application, each patient in the experimental group will be taught the correct breathing technique by explaining the importance of heavy, deep and quiet breathing. As of the third week, progressive relaxation exercises will be applied to six different patients in groups of two in the hospital environment once a week in three sessions during the day for a total of six weeks with the researcher. In addition, the patients will be expected to repeat the progressive relaxation exercises in their home environment two days a week and will be asked to fill out follow-up charts. The individuals in the control group will not be given any training by the researcher. At the end of eight weeks, the individuals in the experimental and control groups will be asked to fill in the Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS) again. Trainings and administration of the forms will be conducted in an empty room allocated for the researcher.
- Conditions
- Anxiety Disorder/Anxiety State
- Being tested
- Progressive relaxation exercises and sleep hygiene training
- Keywords
- Sleep hygiene, Anxiety, progressive relaxation exercise, anxiety disorder
- Medical subject headings
- Anxiety Disorders, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exercises and sleep hygiene trainingBehavioural
Voluntary Consent Form, Personal Information Form, Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS) will be applied to the patients in the experimental group in the first week of the 7-week study. Data will be collected by face-to-face interviews with the patients. After seven weeks, an appointment will be given for the post-test. In the second week, those in the experimental group will be taught progressive relaxation exercise using a compact disc (CD) prepared by the Turkish Psychological Association in the hospital and after the sleep hygiene training, progressive relaxation exercise brochure and sleep hygiene training brochure will be distributed. Starting from the second week, the individuals in the experimental group will be expected to apply the trainings given in the hospital accompanied by the researcher two days a week for six weeks and to apply the trainings given to the individuals at home on the other days of the week.
| Study group | Role | What they receive |
|---|---|---|
| Progressive relaxation exercise and sleep hygiene training | Experimental | It is planned to include 26 patients in the experimental group. Voluntary Consent Form, Personal Information Form, Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS) will be applied to the patients in the experimental group in the first week of the 7-week study. Data will be collected by face-to-face interviews with the patients and an appointment will be made for the post-test after seven weeks. In the second week, the individuals in the experimental group will be taught progressive relaxation exercise in the hospital environment by the researcher using the compact disc (CD) prepared by the Turkish Psychological Association and after the sleep hygiene training, the progressive relaxation exercise brochure and sleep hygiene training brochure created by the researcher will be distributed. As of the second week, the individuals in the experimental group will be expected to apply the trainings given twice in the hospital environment. Receives: Behavioral: Progressive relaxation exercises and sleep hygiene training |
| Control group | No intervention | It is planned to include 26 patients in the control group. Voluntary Consent Form, Personal Information Form, Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS) will be applied to the individuals in the control group in the first week of the 7-week research programme. Data will be collected by face-to-face interview with the patients. Individuals in the control group will not be given any training by the researcher. Individuals in the control group will be given an appointment for the post-test after seven weeks. At the end of seven weeks, individuals in the control group will be asked to fill in the Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS) again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Scale (BAS)
Developed in 1988, its Turkish validity and reliability was performed by Ulusoy et al. (1998) and cronbach alpha was found to be 0.93. It is a 4-point Likert-type scale consisting of 21 questions aiming to measure the severity of anxiety of the individual. Each question is scored between 0-3. The total score obtained from the scale indicates low level of anxiety if the score is between 8-15 points, moderate level of anxiety if the score is between 16-25 points, and high level of anxiety if the score is between 26-63 points.
Measured: seven weeks
Secondary outcomes (2)
Pittsburgh Sleep Quality Index (PSQI)
A PDQI score greater than 5 indicates poor sleep quality. The scale The validity and reliability study in Turkey was conducted by Ağargün et al. in 1996. The Cronbach's alpha reliability coefficient of the scale was 0.804. was found. The sleep quality scale consists of 18 self-report questions and assesses sleep quality in the last 4 weeks. PDQI consists of 18 items and 7 component scores. grouped. Some of the components are indicated by a single item, others are is obtained by combining several items. Each item is scored on a 0-3 point scale. is evaluated. The sum of the 7 component scores has a value between 0-21. Total A high score indicates poor sleep quality.
Measured: seven weeks
Sleep Hygiene Index (SHI)
It was developed by Mastin et al. (2006). Its Turkish validity and reliability was conducted by Özdemir et al. The scale consists of 13 questions and has a five-point Likert scale format (none: 1, rarely: 2, sometimes: 3, often: 4, always: 5). The index is based on the participant's sleep hygiene It aims to assess the presence of sleep hygiene by questioning how often the participant performs sleep behaviors. Scores range from 13 to 65, with higher scores indicating worse sleep hygiene status of the participant. The items that make up the Sleep Hygiene Index are derived from the diagnostic criteria for poor sleep hygiene in the International Classification of Sleep Disorders. The Cronbach Alpha value of the Sleep Hygiene Index was calculated as 0.70 and found to be valid and reliable.
Measured: seven weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start16 Jan 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorder/Anxiety StateStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Model description
- two groups with experimental and control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Eda Bal, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056284
- Sponsor's protocol ID
- SaglikBilimleriU-SBE-NEB-01
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercise and Sleep Hygiene Training on Sleep Quality and AnxietyLevel Given to Outpatients With Anxiety Disorder in Psychiatry Outpatient Clinic
- ClinicalTrials.gov ID
- NCT06056284
- Acronym / sponsor ID
- SaglikBilimleriU-SBE-NEB-01
- Conditions
- Anxiety Disorder/Anxiety State
- Keywords
- Sleep hygiene, Anxiety, progressive relaxation exercise, anxiety disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 28 Sep 2023 (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.
The aim of this study was to investigate the effect of progressive relaxation exercise and sleep hygiene training on sleep quality and anxiety levels in patients diagnosed with anxiety disorder admitted to psychiatry outpatient clinic.
Detailed description
The population of the study consisted of 1417 patients diagnosed with anxiety disorder who applied to the psychiatry outpatient clinic of Ankara Kızılcahamam State Hospital between December 2021 and February 2022. For the pretest-posttest control group research, the required sample size was determined as 47 using the G*Power 3.1.9.4 program with 95% power based on Cohen's d = 0.5 medium effect size alpha = 0.05. However, considering the data loss that may occur in the study, the sample size was determined as 52 when the dropout rate was determined as 10%. The age range of the research sample is 18-75 years old. Individuals who agree to participate in the study and meet the inclusion criteria will be assigned to the experimental and control groups by simple random sampling method. It is planned to include 26 patients in both the experimental and control groups. In the first week of this 8-week research program, the individuals in the experimental and control groups will be administered the Voluntary Consent Form, Personal Information Form consisting of 17 questions prepared by the researcher by reviewing the literature, Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS). Data will be collected by face-to-face interviews with the patients. Individuals in the experimental and control groups will be given an appointment for the posttest eight weeks later. In the second week, individuals in the experimental group will be given sleep hygiene training and a sleep hygiene brochure prepared in line with the literature. In addition, a compact disc (CD) prepared by the Turkish Psychological Association and a training brochure developed by the researcher in line with the progressive relaxation exercises CD, which includes the steps of progressive relaxation exercise application, will be used to teach the progressive relaxation exercise.
The first part of the CD includes a 10-minute description of deep relaxation, its purpose and information to be considered during the exercise. In the second 30-minute part, relaxation exercises are explained with the sound of a stream and verbal instructions. The last 30-minute section included only relaxation music without audio instructions. Before the application, each patient in the experimental group will be taught the correct breathing technique by explaining the importance of heavy, deep and quiet breathing. As of the third week, progressive relaxation exercises will be applied to six different patients in groups of two in the hospital environment once a week in three sessions during the day for a total of six weeks with the researcher. In addition, the patients will be expected to repeat the progressive relaxation exercises in their home environment two days a week and will be asked to fill out follow-up charts. The individuals in the control group will not be given any training by the researcher. At the end of eight weeks, the individuals in the experimental and control groups will be asked to fill in the Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS) again. Trainings and administration of the forms will be conducted in an empty room allocated for the researcher.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups with experimental and control group
| Arm | Type | Receives |
|---|---|---|
| Progressive relaxation exercise and sleep hygiene training | Experimental | Behavioral: Progressive relaxation exercises and sleep hygiene trainingIt is planned to include 26 patients in the experimental group. Voluntary Consent Form, Personal Information Form, Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS) will be applied to the patients in the experimental group in the first week of the 7-week study. Data will be collected by face-to-face interviews with the patients and an appointment will be made for the post-test after seven weeks. In the second week, the individuals in the experimental group will be taught progressive relaxation exercise in the hospital environment by the researcher using the compact disc (CD) prepared by the Turkish Psychological Association and after the sleep hygiene training, the progressive relaxation exercise brochure and sleep hygiene training brochure created by the researcher will be distributed. As of the second week, the individuals in the experimental group will be expected to apply the trainings given twice in the hospital environment. |
| Control group | No intervention | –It is planned to include 26 patients in the control group. Voluntary Consent Form, Personal Information Form, Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS) will be applied to the individuals in the control group in the first week of the 7-week research programme. Data will be collected by face-to-face interview with the patients. Individuals in the control group will not be given any training by the researcher. Individuals in the control group will be given an appointment for the post-test after seven weeks. At the end of seven weeks, individuals in the control group will be asked to fill in the Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS) again. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- To be between the ages of 18 and 60
- Having been diagnosed with anxiety disorder at least 6 months ago
- No barriers in Turkish oral and written communication
- Volunteering to participate in the research
- Not having received progressive relaxation exercise and sleep hygiene training before
Key exclusion criteria (4 listed)
- The individual has conditions that impair the ability to assess reality, such as psychosis, being in the manic phase of bipolar disorder
- Chronic Obstructive Pulmonary Disease (COPD), Heart Failure, asthma, Musculoskeletal System Diseases, etc. that may prevent progressive relaxation exercise
- The individual has participated in another progressive relaxation exercise and/or sleep hygiene training programme
- The individual is taking a psychiatric drug with a relaxant effect
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 |
|---|---|---|
| Progressive relaxation exercises and sleep hygiene trainingVoluntary Consent Form, Personal Information Form, Pittsburgh Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI) and Beck Anxiety Scale (BAS) will be applied to the patients in the experimental group in the first week of the 7-week study. Data will be collected by face-to-face interviews with the patients. After seven weeks, an appointment will be given for the post-test. In the second week, those in the experimental group will be taught progressive relaxation exercise using a compact disc (CD) prepared by the Turkish Psychological Association in the hospital and after the sleep hygiene training, progressive relaxation exercise brochure and sleep hygiene training brochure will be distributed. Starting from the second week, the individuals in the experimental group will be expected to apply the trainings given in the hospital accompanied by the researcher two days a week for six weeks and to apply the trainings given to the individuals at home on the other days of the week. | Behavioural | Progressive relaxation exercise and sleep hygiene training |
Primary outcome
Beck Anxiety Scale (BAS)
Time frame: seven weeks
Developed in 1988, its Turkish validity and reliability was performed by Ulusoy et al. (1998) and cronbach alpha was found to be 0.93. It is a 4-point Likert-type scale consisting of 21 questions aiming to measure the severity of anxiety of the individual. Each question is scored between 0-3. The total score obtained from the scale indicates low level of anxiety if the score is between 8-15 points, moderate level of anxiety if the score is between 16-25 points, and high level of anxiety if the score is between 26-63 points.
2 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: seven weeks
Sleep Hygiene Index (SHI)
Time frame: seven weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive relaxation exercises and sleep hygiene training in people with Anxiety Disorder/Anxiety State, run by Saglik Bilimleri Universitesi 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 4 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nur Eda BAL, MSc (+90 507 333 33 38, nuredabal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Scale (BAS) (time frame: seven weeks). 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 28 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.