Pain, Sleep Quality, Eating Habits and Physical Activity Level in Patients With Bipolar Disorder

NCT06954350 | Enrolling By Invitation

• 1 other identifier: 2024/14-10
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bipolar Disorder (BD)

Keywords

Bipolar Disorder; Pain; Sleep Quality

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At enrollment

Secondary Outcomes (1)

• Pittsburgh sleep quality index

  At enrollment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Being diagnosed with bipolar disorder

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Helath Sciences Faculty

Kütahya, Merkez, 43020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bipolar Disorder; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assos. Prof.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 1, 2025
• Study Start: February 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 28, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

TU (1)