Clinical trial NCT06056284: The Effect of Progressive Relaxation Exercise and Sleep Hygiene Training on Sleep Quality and AnxietyLevel Given to Outpatients With Anxiety Disorder in Psychiatry Clinic
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorder/Anxiety State
Keywords: Sleep hygiene
Anxiety
progressive relaxation exercise
anxiety disorder
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups with experimental and control group
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Beck Anxiety Scale (BAS)
timeFrame: seven weeks
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: seven weeks
measure: Sleep Hygiene Index (SHI)
timeFrame: seven weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Kızılcahamam State Hospital
state: Kızılcahamam
Study officials:
References: