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

Fibromyalgia Clinical Trial

Official title:

Associate Professor Registered Nurse Doctor of Philosophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06276855
• Other study ID #: CUtülay
• Status: Completed
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2024
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Turkey	Sivas Cumhuriyet University	Sivas	Center

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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