Clinical trial NCT06742814: Effects of Stress Ball Use for Patients Undergoing Local Anesthesia in Ambulatory Surgery
Official title: Effects of Stress Ball Use for Patients Undergoing Local Anesthesia in Ambulatory Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: anxiety
stress ball
ambulatory surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate Variability
timeFrame: 3 minutes
Secondary outcomes:
measure: State-Trait Anxiety Inventory, S-TAI
timeFrame: 5 - 10 minutes
measure: Visual Analogue Scale
timeFrame: 3 minutes
Other outcomes:
Locations:
Study officials:
affiliation: NTUH Hsin-Chu Branch
name: Hsueh-Ling Chang
role: STUDY_CHAIR
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