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

Associate Professor Registered Nurse Doctor of Philosophy

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Sleep hygiene education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Center
    • Sivas, Center, Turkey, 58140
      • Sivas Cumhuriyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The DIF, PSQI, VAS, and BDI were also administered to individuals in the control group during the first interview, but no education was provided to them. The participants were given an appointment to meet at the hospital one month later. At the final polyclinic appointment one month later, the VAS, PSQI, and BDI were administered for the second time and took an average of 15-20 minutes to complete. In line with ethical principles, they were provided with individual education on sleep hygiene and sleep hygiene education booklets at the final polyclinic appointment. The same researcher collected the data and provided the education to avoid bias.
Experimental: Experimental group; During the first interview, the DIF, PSQI, VAS, and BDI were administered to individuals in the experimental group. Each education session lasted an average of 30 minutes and was conducted face-to-face. Sleep hygiene education booklets were provided to individuals at the end of the education session. Studies suggest that at least one month should pass for behavioral change to occur after the education session. Therefore, the participants were given an appointment to meet at the hospital one month later. At the final interview one month after the education, the VAS, PSQI, and BDI were administered for the second and final time and took an average of 15-20 minutes to complete.	Other: Sleep hygiene education; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Information Form (DIF).	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.).	1 month
Pittsburgh Sleep Quality Index (PSQI).	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.	1 month
Visual Analog Scale (VAS).	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.	1 month
Beck Depression Inventory (BDI).	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.	1 month

Collaborators and Investigators

• Sponsor: Cumhuriyet University

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Pain; Sleep Quality; Fibromyalgia; Sleep Hygiene
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: CUtülay

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No