Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06742814
Enrollment
74
Registered
2024-12-19
Start date
2025-01-01
Completion date
2025-12-22
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

anxiety, stress ball, awake surgery, Heart Rate Variability

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.

Interventions

DEVICEstress ball

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate Variability5 minutesIt 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

MeasureTime frameDescription
State-Trait Anxiety Inventory, S-TAI5 - 10 minutesIt is based on the individual's feelings in a specific situation.
Visual Analogue Scale3 minutesMeasure the patient's pain level using VAS 0 to 10

Countries

Taiwan

Contacts

STUDY_CHAIRHsueh-Ling Chang

NTUH Hsin-Chu Branch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026