Effects of Stress Ball Use on Heart Rate Variability, Anxiety, and Pain During Awake Hand Surgery: A Randomized Controlled Trial

National Taiwan University Hospital74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anxiety

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria were: (1) age ≥ 18 years and able to communicate in Mandarin or Taiwanese Hokkien; and (2) scheduled to undergo outpatient hand surgery under local anesthesia. Exclusion criteria were: (1) use of anxiolytics or sedatives within one week prior to surgery; (2) concurrent bilateral hand surgery during the same operative session; and (3) known cardiac arrhythmia or use of a cardiac pacemaker.

Outcomes

Primary Outcomes

Heart Rate Variability

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).

Time frame: 5 minutes

Secondary Outcomes

State-Trait Anxiety Inventory, S-TAI

It is based on the individual's feelings in a specific situation.

Time frame: 5 - 10 minutes

Visual Analogue Scale

Measure the patient's pain level using VAS 0 to 10

Time frame: 3 minutes