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Clinical Trials/NCT06276855
NCT06276855
Completed
Not Applicable

Associate Professor Registered Nurse Doctor of Philosophy

Cumhuriyet University1 site in 1 country70 target enrollmentJune 23, 2021
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Cumhuriyet University
Enrollment
70
Locations
1
Primary Endpoint
Pittsburgh Sleep Quality Index (PSQI).
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 23, 2021
End Date
December 31, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tülay Kars Fertelli

Assoc. Prof

Cumhuriyet University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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.).

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.

Study Sites (1)

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