CompletedNot Applicable

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

Turkey (Türkiye)70 participantsStarted 2021-06-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Demographic Information Form (DIF).

Timeframe: 1 month

Pittsburgh Sleep Quality Index (PSQI).

Timeframe: 1 month

Visual Analog Scale (VAS).

Timeframe: 1 month

Beck Depression Inventory (BDI).

Timeframe: 1 month

Trial details

NCT IDNCT06276855

SponsorCumhuriyet University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-01

View on ClinicalTrials.gov More Fibromyalgia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.