NCT06056284

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

September 20, 2023

Last Update Submit

September 20, 2023

Conditions

Anxiety Disorder/Anxiety State

Keywords

Sleep hygieneAnxietyprogressive relaxation exerciseanxiety disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pittsburgh Sleep Quality Index (PSQI)

    seven weeks

  • Sleep Hygiene Index (SHI)

    seven weeks

Study Arms (2)

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.

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.

Interventions

Progressive relaxation exercises and sleep hygiene trainingBEHAVIORAL

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.

Progressive relaxation exercise and sleep hygiene training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kızılcahamam State Hospital

Ankara, Kızılcahamam, 06890, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersSleep Hygiene

Condition Hierarchy (Ancestors)

Mental DisordersHealth BehaviorBehavior

Central Study Contacts

Nur Eda BAL, MSc

CONTACT

+90 507 333 33 38nuredabal@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The experimental group will be subjected to progressive relaxation exercise and the outcome assesment will be performend by an outcomes assessor blinded to group allocation
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two groups with experimental and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
investigator

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

January 16, 2023

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

TU(1)