Effects of Stress Ball Use for Patients Undergoing Local Anesthesia in Ambulatory Surgery

Not Applicable

Not yet recruiting

• Conditions: Anxiety

• Registration Number: NCT06742814
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Preoperative anxiety begins from the decision-making of surgery to entering the operating room and may intensify as the surgery date approaches. Anxiety not only causes physiological effects but also psychological impacts, leading to negative outcomes for postoperative recovery. Ambulatory surgeries often employ local anesthesia, where patients remain conscious during the procedure, potentially causing specific anxieties and fears. The use of a stress ball is a non-pharmacological method that effectively distracts individuals consciously focusing on stimuli. This study is expected to be a randomized controlled trial, using convenience sampling to select patients receiving local anesthesia. They will be divided into two groups through computer-generated random number sequences: the stress ball group and the control group. The research aims to alleviate anxiety and pain levels in outpatient surgery patients receiving local anesthesia, with the goal of improving patients' postoperative mental health and quality of care.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-15
• Study First Posted: 2024-12-19
• Last Update Submitted: 2024-12-22
• Last Update Posted: 2024-12-27
• Study Start: 2025-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• 1. Those who are over 18 years old, have clear consciousness and can communicate in Chinese and Taiwanese Hakka.

2. Patients undergoing outpatient surgery under local anesthesia.

Exclusion Criteria

• Unable to cooperate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability	3 minutes	It is a physiological monitoring indicator. When the human body receives internal and external environmental stimuli, the autonomic nervous system regulates the heart rhythm to perform a series of responses to the stimulus source (Huang et al., 2008). Heart Rate Variability (HRV) is an objective physiological indicator that can be used An assessment tool for anxiety status during surgery (Correa et al., 2021; Tang et al., 2006).

Secondary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory, S-TAI	5 - 10 minutes	It is based on the individual's feelings in a specific situation.
Visual Analogue Scale	3 minutes	Measure the patient's pain level using VAS 0 to 10