FibromyalgiaNCT06276855
Sleep Hygiene Education in Individuals With Fibromyalgia; Sleep Quality, Pain and Depression
A study testing Sleep hygiene education in people with Fibromyalgia, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Sleep hygiene education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- Not having received similar education on sleep hygiene,
- Having a VAS pain score >3,
- Having a PSQI score >5.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, Center, 58140
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Sleep hygiene education
- Keywords
- Sleep Hygiene, Sleep Quality, Pain, Depression, Fibromyalgia
- Medical subject headings
- Fibromyalgia, Sleep Hygiene, Sleep Initiation and Maintenance Disorders, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep hygiene educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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 group | Experimental | 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. Receives: Other: Sleep hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start23 Jun 2021
- Primary completion1 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group Control group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülay Kars Fertelli, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276855
- Sponsor's protocol ID
- CUtülay
- Status last verified
- Feb 2024
- First submitted
- 22 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associate Professor Registered Nurse Doctor of Philosophy
- ClinicalTrials.gov ID
- NCT06276855
- Acronym / sponsor ID
- CUtülay
- Conditions
- Fibromyalgia
- Keywords
- Sleep Hygiene, Sleep Quality, Pain, Depression, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group Control group
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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 group | Experimental | Other: Sleep hygiene educationDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep hygiene educationThe 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. | Other | Experimental group |
Primary outcome
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.).
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep hygiene education in people with Fibromyalgia, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Information Form (DIF). (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.