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

NCT06742814 | Completed

• 2 other identifiers: 202408018RINDGrant No. 114-HCH069
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety

Keywords

anxiety; stress ball; awake surgery; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• 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).

  5 minutes

Secondary Outcomes (2)

• State-Trait Anxiety Inventory, S-TAI

  5 - 10 minutes

• Visual Analogue Scale

  3 minutes

Study Arms (2)

control group

NO INTERVENTION

usal nursing care

intervation group

EXPERIMENTAL

stress ball

Device: stress ball

Interventions

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.

intervation group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital, Hsin-Chu Branch

Hsinchu, 300, Taiwan

Location

National Taiwan University Hospital, Hsin-Chu Branch

Hsinchu, Taiwan

Location

Related Publications (13)

• Boonstra AM, Schiphorst Preuper HR, Balk GA, Stewart RE. Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain. Pain. 2014 Dec;155(12):2545-2550. doi: 10.1016/j.pain.2014.09.014. Epub 2014 Sep 17.

  PMID: 25239073 RESULT

• Haugen AS, Eide GE, Olsen MV, Haukeland B, Remme AR, Wahl AK. Anxiety in the operating theatre: a study of frequency and environmental impact in patients having local, plexus or regional anaesthesia. J Clin Nurs. 2009 Aug;18(16):2301-10. doi: 10.1111/j.1365-2702.2009.02792.x.

  PMID: 19583663 RESULT

• Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30.

  PMID: 25641687 RESULT

• Karatas TC, Gezginci E. The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):309-317. doi: 10.1097/SGA.0000000000000739. Epub 2023 May 17.

  PMID: 37199436 RESULT

• Klopfenstein CE, Forster A, Van Gessel E. Anesthetic assessment in an outpatient consultation clinic reduces preoperative anxiety. Can J Anaesth. 2000 Jun;47(6):511-5. doi: 10.1007/BF03018941.

  PMID: 10875713 RESULT

• Lee A, Chui PT, Gin T. Educating patients about anesthesia: a systematic review of randomized controlled trials of media-based interventions. Anesth Analg. 2003 May;96(5):1424-1431. doi: 10.1213/01.ANE.0000055806.93400.93.

  PMID: 12707146 RESULT

• Maheshwari D, Ismail S. Preoperative anxiety in patients selecting either general or regional anesthesia for elective cesarean section. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):196-200. doi: 10.4103/0970-9185.155148.

  PMID: 25948900 RESULT

• Myles PS, Urquhart N. The linearity of the visual analogue scale in patients with severe acute pain. Anaesth Intensive Care. 2005 Feb;33(1):54-8. doi: 10.1177/0310057X0503300108.

  PMID: 15957691 RESULT

• Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466.

  PMID: 28186223 RESULT

• Salamon E, Kim M, Beaulieu J, Stefano GB. Sound therapy induced relaxation: down regulating stress processes and pathologies. Med Sci Monit. 2003 May;9(5):RA96-RA101.

  PMID: 12761468 RESULT

• Soltani P, Moaddabi A, Koochek Dezfuli M, Ebrahimikiyasari S, Hosseinnataj A, Rengo S, Tavakoli Tafti K, Spagnuolo G. Evaluating the effect of using anti-stress balls as a distraction technique in reducing pain during inferior alveolar nerve block injection: a randomized clinical trial. Clin Oral Investig. 2023 Aug;27(8):4653-4658. doi: 10.1007/s00784-023-05091-2. Epub 2023 Jun 17.

  PMID: 37328611 RESULT

• Sriramka B, Mallik D, Singh J, Khetan M. Effect of hand-holding and conversation alone or with midazolam premedication on preoperative anxiety in adult patients-A randomised controlled trial. Indian J Anaesth. 2021 Feb;65(2):128-132. doi: 10.4103/ija.IJA_705_20. Epub 2021 Feb 10.

  PMID: 33776087 RESULT

• Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5.

  PMID: 29624026 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Hsueh-Ling Chang

  NTUH Hsin-Chu Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: January 1, 2025
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)