Clinical trial NCT05877937: Humor Therapy and Rheumatoid Arthritis
Official title: Effect of Humor on Pain and Anxiety in Patients With Rheumatoid Arthritis: A Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Rheumatoid Arthritis
Nursing Caries
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: VAS score will evaluate at baseline (immediately before the IV biologic infusion treatment)
measure: Visual Analog Scale (VAS)
timeFrame: VAS score will evaluate direct after the IV biologic infusion treatment
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: STAI scores will evaluate at baseline (immediatley before the IV biologic infusion treatment)
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: STAI scores will evaluate direkt after the IV biologic infusion treatment.
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
Study officials:
affiliation: Eskisehir Osmangazi University, Faculty of Health Science, Department of Internal Medicine Nursing
name: Güler Balci Alparslan
role: STUDY_DIRECTOR
References: