Humor Therapy and Rheumatoid Arthritis

NCT05877937 | Completed

• 1 other identifier: 202042005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, randomized controlled study was to inverstigate the effect of humor on pain and in patients with rheumatoid arthritis (RA) during IV treatment. The main question\[s\] it aims to answer are:

• to compare the effect of humor on pain between two groups of patients with RA who watched a comedy movie (intervention group) and who did not (control group) during IV biological therapy.
• to compare the effect of humor on anxiety between two groups of patients with RA who watched a comedy movie (intervention group) and who did not (control group) during IV biological therapy. Participants in the intervention group watched a comedy movie during routine IV biologic treatment in the chemotherapy unit, while the control group received only routine IV biologic treatment as a usual care.

Conditions

Pain; Anxiety; Rheumatoid Arthritis; Nursing Caries

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS)

  VAS is the pain rating scale. A VAS consists of a line, often 10 cm long, with verbal anchors at either end, similar to an NRS (e.g., "no pain" on the far left and "the most intense pain imaginable" on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.

  VAS score will evaluate at baseline (immediately before the IV biologic infusion treatment)

• Visual Analog Scale (VAS)

  VAS is the pain rating scale. A VAS consists of a line, often 10 cm long, with verbal anchors at either end, similar to an NRS (e.g., "no pain" on the far left and "the most intense pain imaginable" on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.

  VAS score will evaluate direct after the IV biologic infusion treatment

Secondary Outcomes (2)

• State-Trait Anxiety Inventory (STAI)

  STAI scores will evaluate at baseline (immediatley before the IV biologic infusion treatment)

• State-Trait Anxiety Inventory (STAI)

  STAI scores will evaluate direkt after the IV biologic infusion treatment.

Study Arms (2)

Interventions group

EXPERIMENTAL

The intervention group watched a comedy movie during routine IV biologic treatment in the chemotherapy day unit.

Other: Supportive care (Watching a comedy movie)

Control group

NO INTERVENTION

The control group received only routine IV biologic treatment as a usual care.

Interventions

Supportive care (Watching a comedy movie) OTHER

A 10.1 inch Android tablet (2 pieces) and disposable earplugs for each patient were used in the study. A comic film archive was created in line with the recommendation and consultancy of department of state conservatory and performing arts. In this regard, the officials of the Conservatory stated that they had no standardized comedy films specific to society and emphasized that the standardization of art limits art activities. Therefore, there should be no limitations for art. In the film archive cre-ated according to their suggestions, there were a total of five comedy movies, including three Turkish comedies, one foreign romantic comedy, and one foreign Turkish-dubbed family comedy. The original/licensed versions of the movies in this archive were ob-tained and uploaded to the tablet. The movies lasted 90-120 minutes (as long as the av-erage duration of IV treatment). The patients selected the movie that they would watch during the treatment.

Interventions group

Eligibility Criteria

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

You may qualify if:

• having reached the age of 18; having been given a diagnosis of RA in accordance with the ACR/EULAR (Aletaha et al. 2010) classification criteria at least six months prior to the study; receiving IV biologic infusion therapy in the chemotherapy day unit; not having any other inflammatory diseases; experiencing pain that ranged from 4 to 8 on the VAS; not having been given a complex disease, such as cancer; not being pregnant; and having no mental diagnosis, no drug use-related or disease-related impairment of consciousness, no communication issue, and voluntary participation in the study.

You may not qualify if:

• a switch in treatment method during the intervention or any discomfort such as dizzi-ness or nausea while watching a comic film.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Arthritis, Rheumatoid

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Güler Balci Alparslan

  Eskisehir Osmangazi University, Faculty of Health Science, Department of Internal Medicine Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: May 26, 2023
• Study Start: September 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)