NCT06758284

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 26, 2024

Last Update Submit

December 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Anxiety

    40 minutes before ureteroscopy, 5 minutes before ureteroscopy

Study Arms (2)

Laughter Yoga Group

EXPERIMENTAL

1. 40 minutes before the procedure, the patients' surgical fear is evaluated. 2. 40 minutes before the procedure, the patients' state anxiety is evaluated. 3. A single session of laughter yoga is performed. (30 minutes) 4. After laughter yoga, the patients' surgical fear is re-evaluated. 5. After laughter yoga, the patients' state anxiety is re-evaluated.

Other: Laughter Yoga

Control Group

NO INTERVENTION

1. 40 minutes before the procedure, the patients' surgical fear is evaluated. 2. 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.

Interventions

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.

Laughter Yoga Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Gazi State Hospital

Samsun, Samsun, 55000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Central Study Contacts

Hatice Merve Alptekin research assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 3, 2025

Study Start

July 1, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

January 3, 2025

Record last verified: 2024-12

Locations