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

Associate Professor Registered Nurse Doctor of Philosophy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06276855
Enrollment
70
Registered
2024-02-26
Start date
2021-06-23
Completion date
2021-12-31
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Sleep Hygiene, Sleep Quality, Pain, Depression, Fibromyalgia

Brief 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.

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.

Interventions

OTHERSleep 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.

Sponsors

Cumhuriyet University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Experimental group Control group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Demographic Information Form (DIF).1 monthThis 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.).
Pittsburgh Sleep Quality Index (PSQI).1 monthThe 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.
Visual Analog Scale (VAS).1 monthThe 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.
Beck Depression Inventory (BDI).1 monthThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026