The Effect of Progressive Relaxation Exercise and Sleep Hygiene Training on Sleep Quality and AnxietyLevel Given to Outpatients With Anxiety Disorder in Psychiatry Clinic

Anxiety Disorder/Anxiety State Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056284
• Other study ID #: SaglikBilimleriU-SBE-NEB-01
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: September 2023
• Source: Saglik Bilimleri Universitesi
• Contact: Nur Eda BAL, MSc
• Phone: +90 507 333 33 38
• Email: nuredabal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 Kizilcahamam 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

Related Conditions & MeSH terms

• Anxiety Disorder/Anxiety State
• Anxiety Disorders

Intervention

Behavioral:
• Progressive relaxation exercises and sleep hygiene training
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.

Locations

Country	Name	City	State
Turkey	Kizilcahamam State Hospital	Ankara	Kizilcahamam

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	seven weeks
Secondary	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 Agargün 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.	seven weeks
Secondary	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.	seven weeks