Bipolar Disorder (BD)NCT06954350
Pain, Sleep Quality, Eating Habits and Physical Activity Level in Patients With Bipolar Disorder
An observational study of Bipolar Disorder (BD), run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Bipolar disorder (BD) is a complex condition characterized by recurrence of mania, hypomania, and depression. It is characterized by changes in daily life activities, sleep status, focus problems, and cognitive fluctuations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder (BD)
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 28 Feb 2026
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Being diagnosed with bipolar disorder
Who may be able to join
- Being between the ages of 18 and 65.
- Being diagnosed with bipolar disorder by a psychiatrist according to DSM-5 criteria and not having symptoms of depression and mania at a level that prevents participation in the study.
- Volunteering to participate in the study.
Who cannot join
- Not being able to read and write Turkish.
- Having mental retardation.
- Having suffered a severe head trauma in the last 1 year.
- Having a disease that affects cognitive functions such as dementia.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Helath Sciences Faculty
Kütahya, Merkez, 43020
About this study
Official title: Investigation of Pain, Sleep Quality, Eating Habits and Physical Activity Level in Patients With Bipolar Disorder in Euthymic Period
Bipolar disorder (BD) is a complex condition characterized by recurrence of mania, hypomania, and depression. It is characterized by changes in daily life activities, sleep status, focus problems, and cognitive fluctuations. The mortality rate due to suicide and cardiovascular diseases increases in individuals with BD. The DSM-5TR defines BD as Bipolar I Disorder (BD-1) with one or more manic episodes, Bipolar II Disorder (BD-II) with at least one severe depressive episode accompanied by at least one hypomanic episode, Cyclothymia disorder, substance-induced bipolar disorder, bipolar or related disorder related to another medical condition, other defined bipolar and related disorder, and undefined bipolar and related disorder. The lifetime prevalence of BD varies between 0.6% and 1.0% for Type I and 0.4% and 1.1% for Type II. Symptoms usually start between 14-21 years of age. Depressive episodes and lifelong single marital status are more common in females, while substance abuse is more common in males.
Depression attacks are longer than manias, but the duration of attacks does not differ between types. The mean duration of depressive and manic periods is 5.2 months and 3.5 months, respectively. Pain is observed in 28.9% of patients with a diagnosis of GI, which decreases the quality of life and is a significant concern in psychological disorders.
Read the detailed description
Bipolar disorder (BD) is assumed to be a multifactorial entity including psychosocial and genetic factors whose neurobiology is still unclear. BD is characterised by recurrence of mania, hypomania and depression. In the fluctuations seen in these transitions, individuals may experience changes in daily life activities and sleep status, focussing problems and cognitive fluctuations. The mortality rate due to suicide and cardiovascular diseases increases in individuals with BD. DSM-5TR defines BD as Bipolar I Disorder (BD-1) in the presence of one or more manic episodes, Bipolar II Disorder (BD-II) in the presence of at least one severe depressive episode accompanied by at least one hypomanic episode, Cyclothymia disorder which does not meet the criteria for BD I-II but has a course closer to normal including prolonged hypomanic and depressive episodes, It is classified as substance-induced bipolar disorder which occurs in case of intoxication or withdrawal as a result of the use of drugs or medications, bipolar or related disorder related to another medical condition, other defined bipolar and related disorder including mild and atypical symptoms, and undefined bipolar and related disorder in which symptoms are predominant but diagnostic criteria are not sufficiently present.
The lifetime prevalence of BD is estimated to vary between 0.6% and 1.0% for Type I and between 0.4% and 1.1% for Type II. Symptoms of most of the cases start between 14-21 years of age. Although there are no major differences between genders, depressive episodes and lifelong single marital status are more common in female individuals and substance abuse is more common in male individuals.
In a study examining the duration of attacks, it was reported that depression attacks were much longer than manias, but the duration of attacks did not differ between types and the mean duration of depressive and manic periods were 5.2 months and 3.5 months, respectively. In the manic period, the level of consciousness of the patients is generally clear and attention is increased. However, clouding of consciousness may occur due to reasons such as being physically more active than normal and disrupting or reducing eating patterns. Sudden sleep disturbances such as difficulty falling asleep and waking up at unusual hours may be a sign of mania. Excessive physical activity may cause exhaustion and weight loss with the emergence of nutritional problems. Although consciousness is intact during depression, blurred consciousness may occur in exhausted and numbness depressions. Increased desire for sleep, decreased appetite, exhaustion and decreased sexual desire may be observed.
Pain is observed in 28.9% of patients with a diagnosis of GI. The prevalence of pain in patients, especially chronic pain and migraine, decreases the quality of life and studies in this patient group are limited. Acute pain, on the other hand, has been shown in one study to be 83% of those who felt pain momentarily. Since chronic pain triggers recurrent thoughts of death, pain management should be a part of treatment in psychological disorders.
In the literature, quality of life, sleep disorder, eating disorder, physical activity, suicidal ideation and pain (localisation and intensity) of patients diagnosed with bipolar disorder have been examined separately, but there are few studies on pain in bipolar disorder. In our country, it is observed that there have not been many studies on pain assessment in this patient group.
- Conditions
- Bipolar Disorder (BD)
- Keywords
- Bipolar Disorder, Pain, Sleep Quality
- Medical subject headings
- Bipolar Disorder, Pain, Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensty
The McGill Pain Questionnaire consists primarily of 3 major classes of word descriptors--sensory, affective and evaluative--that are used by patients to specify subjective pain experience. It also contains an intensity scale and other items to determine the properties of pain experience. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.
Measured: at enrollment
Pain quality and type
To assess pain quality and type, participants were asked to choose as many of the words as possible from a list containing 29 adjectives of pain sensation descriptors taken from the McGill Pain Questionnaire (MPQ). Sensations of shooting, stabbing, electric shock-like, nagging, numbness, tingling, and burning were considered as neuropathic pain descriptors, whereas non-neuropathic pain was described as a sharp, aching, or throbbing sensation. Superficial pain descriptors included numbness, tingling, burning, shooting, sharp, pressure, piercing, stinging, hot, smarting, radiating, and cutting, while deep pain descriptors included cramping, tenderness, aching, pulling, pounding, gnawing, soreness, boring, stabbing, troublesome, annoying, dull, nagging, and throbbing.
Measured: At enrollment
Pain distribution
Pain distribution was measured using the Margolis drawing rating system, which has 45 anatomical areas, each with a corresponding percentage value of body surface, in order to compute a total weighted score, indicating body pain distribution.
Measured: At enrollment
Secondary outcomes (1)
Pittsburgh sleep quality index
The questionnaire has a blend of Likert-type and open-ended questions, which are subsequently transformed into scaled scores according to the provided standards.
Participants are requested to specify the frequency of their sleep difficulties encountered in the preceding month and to evaluate their overall sleep quality.Values for each item vary from 0 to 3, with elevated values signifying more severe sleep disruptions.Developers proposed a threshold score of 5 for the global scale, since it accurately identified 88.5% of the patient cohort in their validation research.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Feb 2025
- Primary completion30 Dec 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder (BD)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vedat KURT, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954350
- Sponsor's protocol ID
- 2024/14-10
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pain, Sleep Quality, Eating Habits and Physical Activity Level in Patients With Bipolar Disorder in Euthymic Period
- ClinicalTrials.gov ID
- NCT06954350
- Acronym / sponsor ID
- 2024/14-10
- Conditions
- Bipolar Disorder (BD)
- Keywords
- Bipolar Disorder, Pain, Sleep Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 1 May 2025 (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.
Bipolar disorder (BD) is a complex condition characterized by recurrence of mania, hypomania, and depression. It is characterized by changes in daily life activities, sleep status, focus problems, and cognitive fluctuations. The mortality rate due to suicide and cardiovascular diseases increases in individuals with BD. The DSM-5TR defines BD as Bipolar I Disorder (BD-1) with one or more manic episodes, Bipolar II Disorder (BD-II) with at least one severe depressive episode accompanied by at least one hypomanic episode, Cyclothymia disorder, substance-induced bipolar disorder, bipolar or related disorder related to another medical condition, other defined bipolar and related disorder, and undefined bipolar and related disorder. The lifetime prevalence of BD varies between 0.6% and 1.0% for Type I and 0.4% and 1.1% for Type II. Symptoms usually start between 14-21 years of age. Depressive episodes and lifelong single marital status are more common in females, while substance abuse is more common in males.
Depression attacks are longer than manias, but the duration of attacks does not differ between types. The mean duration of depressive and manic periods is 5.2 months and 3.5 months, respectively. Pain is observed in 28.9% of patients with a diagnosis of GI, which decreases the quality of life and is a significant concern in psychological disorders.
Detailed description
Bipolar disorder (BD) is assumed to be a multifactorial entity including psychosocial and genetic factors whose neurobiology is still unclear. BD is characterised by recurrence of mania, hypomania and depression. In the fluctuations seen in these transitions, individuals may experience changes in daily life activities and sleep status, focussing problems and cognitive fluctuations. The mortality rate due to suicide and cardiovascular diseases increases in individuals with BD. DSM-5TR defines BD as Bipolar I Disorder (BD-1) in the presence of one or more manic episodes, Bipolar II Disorder (BD-II) in the presence of at least one severe depressive episode accompanied by at least one hypomanic episode, Cyclothymia disorder which does not meet the criteria for BD I-II but has a course closer to normal including prolonged hypomanic and depressive episodes, It is classified as substance-induced bipolar disorder which occurs in case of intoxication or withdrawal as a result of the use of drugs or medications, bipolar or related disorder related to another medical condition, other defined bipolar and related disorder including mild and atypical symptoms, and undefined bipolar and related disorder in which symptoms are predominant but diagnostic criteria are not sufficiently present.
The lifetime prevalence of BD is estimated to vary between 0.6% and 1.0% for Type I and between 0.4% and 1.1% for Type II. Symptoms of most of the cases start between 14-21 years of age. Although there are no major differences between genders, depressive episodes and lifelong single marital status are more common in female individuals and substance abuse is more common in male individuals.
In a study examining the duration of attacks, it was reported that depression attacks were much longer than manias, but the duration of attacks did not differ between types and the mean duration of depressive and manic periods were 5.2 months and 3.5 months, respectively. In the manic period, the level of consciousness of the patients is generally clear and attention is increased. However, clouding of consciousness may occur due to reasons such as being physically more active than normal and disrupting or reducing eating patterns. Sudden sleep disturbances such as difficulty falling asleep and waking up at unusual hours may be a sign of mania. Excessive physical activity may cause exhaustion and weight loss with the emergence of nutritional problems. Although consciousness is intact during depression, blurred consciousness may occur in exhausted and numbness depressions. Increased desire for sleep, decreased appetite, exhaustion and decreased sexual desire may be observed.
Pain is observed in 28.9% of patients with a diagnosis of GI. The prevalence of pain in patients, especially chronic pain and migraine, decreases the quality of life and studies in this patient group are limited. Acute pain, on the other hand, has been shown in one study to be 83% of those who felt pain momentarily. Since chronic pain triggers recurrent thoughts of death, pain management should be a part of treatment in psychological disorders.
In the literature, quality of life, sleep disorder, eating disorder, physical activity, suicidal ideation and pain (localisation and intensity) of patients diagnosed with bipolar disorder have been examined separately, but there are few studies on pain in bipolar disorder. In our country, it is observed that there have not been many studies on pain assessment in this patient group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Being diagnosed with bipolar disorder
Key inclusion criteria (3 listed)
- Being between the ages of 18 and 65.
- Being diagnosed with bipolar disorder by a psychiatrist according to DSM-5 criteria and not having symptoms of depression and mania at a level that prevents participation in the study.
- Volunteering to participate in the study.
Key exclusion criteria (4 listed)
- Not being able to read and write Turkish.
- Having mental retardation.
- Having suffered a severe head trauma in the last 1 year.
- Having a disease that affects cognitive functions such as dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Intensty
Time frame: at enrollment
The McGill Pain Questionnaire consists primarily of 3 major classes of word descriptors--sensory, affective and evaluative--that are used by patients to specify subjective pain experience. It also contains an intensity scale and other items to determine the properties of pain experience. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.
Pain quality and type
Time frame: At enrollment
To assess pain quality and type, participants were asked to choose as many of the words as possible from a list containing 29 adjectives of pain sensation descriptors taken from the McGill Pain Questionnaire (MPQ). Sensations of shooting, stabbing, electric shock-like, nagging, numbness, tingling, and burning were considered as neuropathic pain descriptors, whereas non-neuropathic pain was described as a sharp, aching, or throbbing sensation. Superficial pain descriptors included numbness, tingling, burning, shooting, sharp, pressure, piercing, stinging, hot, smarting, radiating, and cutting, while deep pain descriptors included cramping, tenderness, aching, pulling, pounding, gnawing, soreness, boring, stabbing, troublesome, annoying, dull, nagging, and throbbing.
Pain distribution
Time frame: At enrollment
Pain distribution was measured using the Margolis drawing rating system, which has 45 anatomical areas, each with a corresponding percentage value of body surface, in order to compute a total weighted score, indicating body pain distribution.
1 secondary outcome
Pittsburgh sleep quality index
Time frame: At enrollment
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 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Bipolar Disorder (BD), run by Kutahya Health Sciences 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 3 inclusion and 4 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 4 Aug 2026. 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?
Pain Intensty (time frame: at enrollment). The study lists 3 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 4 Aug 2026.