Clinical trial NCT06954350: Pain, Sleep Quality, Eating Habits and Physical Activity Level in Patients With Bipolar Disorder
Official title: Investigation of Pain, Sleep Quality, Eating Habits and Physical Activity Level in Patients With Bipolar Disorder in Euthymic Period
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bipolar Disorder (BD)
Keywords: Bipolar disorder, Pain, sleep quality
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Being diagnosed with bipolar disorder

Brief summary: Bipolar disorder (BD) is assumed to be a multifactorial entity including psychosocial and genetic factors whose neurobiology is still unclear.(1) 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 (2). 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 (3).

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 (4). Symptoms of most of the cases start between 14-21 years of age (5). 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 (6).

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 (7). 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 (8). Increased desire for sleep, decreased appetite, exhaustion and decreased sexual desire may be observed (9).

Pain is observed in 28.9% of patients with a diagnosis of GI (10). The prevalence of pain in patients, especially chronic pain and migraine, decreases the quality of life and studies in this patient group are limited (11). Acute pain, on the other hand, has been shown in one study to be 83% of those who felt pain momentarily (12). Since chronic pain triggers recurrent thoughts of death, pain management should be a part of treatment in psychological disorders (13).

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 (14-16). In our country, it is observed that there have not been many studies on pain assessment in this patient group.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: McGill Pain Questionnaire
timeFrame: at enrollment
measure: Margolis Pain Diagram
timeFrame: At enrollment
Secondary outcomes:
measure: Pittsburgh sleep quality index
timeFrame: At enrollment
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Helath Sciences Faculty
state: Merkez
Study officials:
References: