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Humor Therapy and Rheumatoid Arthritis

Primary Purpose

Pain, Anxiety, Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supportive care (Watching a comedy movie)
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eskisehir Osmangazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventions group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory was developed in 1970 and adapted to Turkish in 1977 (11,12). This is a four-point Likert-type scale with two parts, where the first and second parts include questions to determine one's state and trait anxiety levels, respectively. Our study used the first part, called the State Anxiety Scale. The total scale score varies between 20 and 80. A higher score indicates higher anxiety. The Cronbach's alpha is 0.82 for the STAI.
State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory was developed in 1970 and adapted to Turkish in 1977 (11,12). This is a four-point Likert-type scale with two parts, where the first and second parts include questions to determine one's state and trait anxiety levels, respectively. Our study used the first part, called the State Anxiety Scale. The total scale score varies between 20 and 80. A higher score indicates higher anxiety. The Cronbach's alpha is 0.82 for the STAI.

Full Information

First Posted
March 2, 2023
Last Updated
May 17, 2023
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05877937
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Rheumatoid Arthritis, Nursing Caries

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventions group
Arm Type
Experimental
Arm Description
The intervention group watched a comedy movie during routine IV biologic treatment in the chemotherapy day unit.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group received only routine IV biologic treatment as a usual care.
Intervention Type
Other
Intervention Name(s)
Supportive care (Watching a comedy movie)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
VAS score will evaluate at baseline (immediately before the IV biologic infusion treatment)
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
VAS score will evaluate direct after the IV biologic infusion treatment
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI)
Description
The State-Trait Anxiety Inventory was developed in 1970 and adapted to Turkish in 1977 (11,12). This is a four-point Likert-type scale with two parts, where the first and second parts include questions to determine one's state and trait anxiety levels, respectively. Our study used the first part, called the State Anxiety Scale. The total scale score varies between 20 and 80. A higher score indicates higher anxiety. The Cronbach's alpha is 0.82 for the STAI.
Time Frame
STAI scores will evaluate at baseline (immediatley before the IV biologic infusion treatment)
Title
State-Trait Anxiety Inventory (STAI)
Description
The State-Trait Anxiety Inventory was developed in 1970 and adapted to Turkish in 1977 (11,12). This is a four-point Likert-type scale with two parts, where the first and second parts include questions to determine one's state and trait anxiety levels, respectively. Our study used the first part, called the State Anxiety Scale. The total scale score varies between 20 and 80. A higher score indicates higher anxiety. The Cronbach's alpha is 0.82 for the STAI.
Time Frame
STAI scores will evaluate direkt after the IV biologic infusion treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Güler Balci Alparslan
Organizational Affiliation
Eskisehir Osmangazi University, Faculty of Health Science, Department of Internal Medicine Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Eskisehir Osmangazi University
City
Eskisehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Humor Therapy and Rheumatoid Arthritis

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