Humor Therapy and Rheumatoid Arthritis

NCT ID: NCT05877937

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-11-30

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.

Detailed Description

Settings and Participants This study included a total of 36 patients who were diagnosed with RA according to the criteria of the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) (Aletaha et al. 2010) and received IV biological drug therapy in the chemotherapy day unit of an oncology clinic between September 2020 and November 2021. In addition to hematological and oncological patients receiving outpatient chemotherapy, patients receiving outpatient IV/subcutaneous biologic drug therapy were also treated in the chemotherapy day unit. As a result of the posterior power analysis, the power was calculated as 1.00 (100%) for the VAS with n=36. The patients were randomized allocated two groups: Intervention group and control group. Both groups received routine IV biologic treatment.The allocation ratio was set 1:1.

Inclusion criteria The following study inclusion criteria were used: having reached the age of 18; having been given a diagnosis of RA in accordance with the ACR/EULAR (9) 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.

Exclusion criteria The exclusion criteria were the following: a switch in treatment method during the intervention or any discomfort such as dizziness or nausea while watching a comic film.

Outcomes were assessed as pre-post test immediately before and after the IV biologic infusion treatment:

• Pre-test: Before the IV infusion treatment, the patients were evaluated face-to-face by the researcher in an empty quiet examination room in the chemotherapy day unit using a descriptive information form, the Visual Analog Scale (VAS), and the State-Trait Anxiety Inventory (STAI).
• Post-test: After the IV infusion treatment (post-test), the patients were re-evaluated using the VAS and the SAI.

Conditions

Pain; Anxiety; Rheumatoid Arthritis; Nursing Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Interventions group

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

Group Type: EXPERIMENTAL

Supportive care (Watching a comedy movie)

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Supportive care (Watching a comedy movie)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

Güler Balci Alparslan

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Güler Balci Alparslan

Role: STUDY_DIRECTOR

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

Locations

Eskisehir Osmangazi University

Eskişehir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

202042005

Identifier Type: -

Identifier Source: org_study_id