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NCT Number: NCT06742814

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Hsin-Chu Branch, Hsinchu, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

stress ball

Device

Stress ball: It is a ball with moderate hardness and softness, about 6 cm, which can be held and pressed by hand.

Primary outcomes

  1. Heart Rate Variability

    Time frame: 5 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 outcomes

  1. State-Trait Anxiety Inventory, S-TAI

    Time frame: 5 - 10 minutes

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

  2. Visual Analogue Scale

    Time frame: 3 minutes

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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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