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NCT Number: NCT06276855

Sleep Hygiene Education in Individuals With Fibromyalgia; Sleep Quality, Pain and Depression

Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.

Patients and methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory.

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Key information

Conditions

Fibromyalgia Behavior Behavioral Symptoms Depression Dyssomnias Health Behavior Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Sleep Disorders, Intrinsic Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sivas Cumhuriyet University

Sivas, Center, 58140, Turkey (Türkiye)

About this study

Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.

Background: Sleep problems, pain, and depression are common health issues in individuals with fibromyalgia. However, studies on sleep hygiene education to address these problems are limited in the literature.

Methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The inclusion criteria for the study were as follows:

  • Being 18 years of age or older,
  • Having a diagnosis of Fibromyalgia (FM) for at least 3 months,
  • Being reachable,
  • Agreeing to participate in the study,
  • Not receiving treatment for depression,
  • Not having received similar education on sleep hygiene,
  • Having a VAS pain score >3,
  • Having a PSQI score >5.

Exclusion criteria

Additionally, the exclusion criteria for the study were as follows:

  • Having a diagnosis of FM for less than 3 months,
  • Using sleep medication,
  • Having chronic illnesses that could interfere with sleep such as Chronic Obstructive Pulmonary Disease (COPD) or asthma,
  • Working on night shifts.

Treatment and study plan

Sleep hygiene education

Other

The sleep hygiene education booklet was prepared by the researchers by in line with the literature. The booklet contains information on the definition and benefits of sleep, sleep problems during insomnia, arrangements for regular sleep, and the principles of sleep hygiene. The principles of sleep hygiene include individual habits that facilitate sleep, proper arrangement of the physical environment, exercises before going to bed, and dietary habits. This educational content was applied to those in the experimental group. The education took an average of 30 minutes.

Primary outcomes

  1. Demographic Information Form (DIF).

    Time frame: 1 month

    This form was prepared by the researcher based on the literature and consists of 10 questions about the FM patients' sociodemographic and disease characteristics (age, gender, educational status, etc.).

  2. Pittsburgh Sleep Quality Index (PSQI).

    Time frame: 1 month

    The PSQI evaluates the quality of sleep in the last month. It consists of 19 items and 7 components. Each item is evaluated on a 0-3 point scale, and the sum of scores from seven components gives the total PSQI score. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. A total PSQI score of ≤5 indicates "good sleep," while a score of >5 indicates "poor sleep." The Cronbach's alpha value of the scale is 0.80. In this study, the Cronbach's alpha was found to be 0.83.

  3. Visual Analog Scale (VAS).

    Time frame: 1 month

    The VAS is a valid and reliable scale to measure the intensity of chronic pain. It is rated from "0 = no pain" to "10 = worst possible pain". The intervals for pain intensity are <3 for mild pain, 3-6 for moderate pain, and >6 for severe pain. The Cronbach's alpha value of the scale is 0.97. In this study, the Cronbach's alpha was found to be 0.92.

  4. Beck Depression Inventory (BDI).

    Time frame: 1 month

    The scale consists of a total of 21 items. The highest possible total score is 63. A high total score indicates a higher level of depression. The severity of depression is categorized as follows: 0-9 = minimal, 10-16 = mild, 17-29 = moderate, and 30-63 = severe depression. The internal consistency coefficient of the scale is 0.86. In this study, the Cronbach's alpha was found to be 0.83.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

Associate Professor Registered Nurse Doctor of Philosophy

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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