Effect of Laughter Yoga on Surgical Fear and Anxiety in Patients Applied Before Ureteroscopy

Effect of Laughter Yoga on Surgical Fear and Anxiety in Patients Applied Before Ureteroscopy: a Randomized Controlled Trial

Surgical fear is a situation where a person experiences excessive fear of surgical procedures. This fear can negatively affect the person's normal life and is usually more intense in the pre-operative period. The causes of surgical fear include factors such as previous negative surgical experiences, lack of sufficient information, post-operative pain and complications. In addition, factors such as age, gender, and level of education can also affect fear. This fear can lead to physical and psychological problems along with stress; symptoms such as increased heart rate, dizziness, and muscle tension can be seen. Methods such as cognitive-behavioral therapy, meditation, and hypnosis can be used in the treatment of surgical fear. In addition, anxiety can also arise from thinking about the surgical procedure, post-operative complications, fear of anesthesia, or pain. High-risk surgeries and past negative experiences can increase anxiety. High anxiety before surgery can lead to psychological and physical problems. Nurses should offer anxiety-reducing techniques (breathing exercises, relaxation) by taking into account the needs of patients. In addition, having relatives with the patient can help relieve anxiety. Laughter yoga is considered an effective complementary therapy to reduce surgical fear and anxiety. Developed in India in 1995, this method involves simulating laughter with yoga breathing techniques. Laughter yoga relaxes muscles, increases pain threshold, and improves overall psychological well-being. This study aims to evaluate the effects of laughter yoga on patients undergoing ureteroscopy.

Study Overview

• Status: Recruiting
• Conditions: Kidney Stones; Ureteroscopy
• Intervention / Treatment: Other: Laughter Yoga

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hatice Merve Alptekin research assistant; Phone Number: +902623034733; Email: merve.alptekin@kocaeli.edu.tr

Study Locations

• Turkey
  • Samsun, Turkey, 55000
    • Recruiting
    • Samsun Gazi State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

It will be applied to patients who agree to participate in the study, are scheduled to undergo ureteroscopy in a urological surgery clinic, have no hearing or vision problems, are over the age of 18, understand and speak Turkish, are literate, and can communicate.

Exclusion Criteria:

Patients with mental retardation and any psychiatric disorder, alcohol or drug addiction, hypertension or heart disease, hernia, glaucoma will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laughter Yoga Group; 40 minutes before the procedure, the patients' surgical fear is evaluated.; 40 minutes before the procedure, the patients' state anxiety is evaluated.; A single session of laughter yoga is performed. (30 minutes); After laughter yoga, the patients' surgical fear is re-evaluated.; After laughter yoga, the patients' state anxiety is re-evaluated.	Other: Laughter Yoga; The first component of the intervention is laughter therapy, which is a combination of warm-up exercises, deep breathing exercises, childlike playfulness and laughter exercises. Participants will do laughter therapy via WhatsApp video call. Laughter yoga will be a single session and will last approximately 30 minutes.
No Intervention: Control Group; 40 minutes before the procedure, the patients' surgical fear is evaluated.; 40 minutes before the procedure, the patients' situational anxiety is evaluated. 1. 5 minutes before the procedure, the patients' surgical fear is evaluated. 2. 5 minutes before the procedure, the patients' situational anxiety is evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Fear	The "Surgical Fear Questionnaire" will be used to measure patients' fear of surgery. The scale is an 11-point Likert-type scale consisting of 8 items, each item scored between 0 (not afraid at all) and 10 (very afraid). The scale has two sub-dimensions, each consisting of four items; items 1-4 measure fear of short-term outcomes of surgery, while items 5-8 measure fear of long-term outcomes of surgery. The sub-dimension scale score is obtained by summing the scores of each of the short-term and long-term sub-dimensions of the Surgical Fear Scale, and the total score of the scale is calculated by summing these scores. The sub-dimensions of the scale are scored between 0-40, and the total score is scored between 0-80. As the score increases, the patient's fear also increases.	40 minutes before the ureteroscopy procedure, 5 minutes before the ureteroscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Spielberg State-Trait Anxiety Inventory The scale consists of two separate dimensions: state anxiety (STAI-I) and trait anxiety (STAI-II), and these dimensions aim to measure individuals' anxiety in different contexts. The state anxiety section will be used in this study. The 20 items of the scale measure state anxiety. The scale items are in a 4-point Likert type. Responses range from "Never" (1) to "Very often" (4). The state anxiety scale contains 10 reverse (1, 2, 5, 8, 11, 15, 16, 19, 20) and 10 direct statements. The scale is scored between 20-80 and the anxiety level increases as the score increases.	40 minutes before ureteroscopy, 5 minutes before ureteroscopy

Collaborators and Investigators

• Sponsor: Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Nephrolithiasis; Kidney Calculi
• Other Study ID Numbers: 2024/11/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No