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AnxietyNCT06742814

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

A study testing stress ball in people with Anxiety, run by National Taiwan University Hospital at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety
What is being tested?
stress ball
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
2 sitesTaiwan
Study dates
1 Jan 2025to 22 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • National Taiwan University Hospital, Hsin-Chu Branch

    Hsinchu, 300

  • National Taiwan University Hospital, Hsin-Chu Branch

    Hsinchu

Other trials in Taiwan

About this study

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

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
Being tested
stress ball
Keywords
anxiety, stress ball, awake surgery, Heart Rate Variability
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stress ballDevice

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

Study groups in NCT06742814
Study groupRoleWhat they receive
control groupNo interventionusal nursing care
intervation groupExperimentalstress ball
Receives: Device: stress ball

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 5 minutes

Secondary outcomes (2)

  1. State-Trait Anxiety Inventory, S-TAI

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

    Measured: 5 - 10 minutes

  2. Visual Analogue Scale

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

    Measured: 3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2024
  2. Study start1 Jan 2025
  3. Primary completion22 Dec 2025
  4. Study completion22 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06742814
Sponsor's protocol ID
202408018RIND
Other IDs
Grant No. 114-HCH069
Status last verified
Apr 2026
First submitted
15 Dec 2024
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: available upon reasonable request

Publications

  • 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.

    PubMed 25239073

  • 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.

    PubMed 19583663

  • 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.

    PubMed 25641687

  • 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.

    PubMed 37199436

  • 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.

    PubMed 10875713

  • 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.

    PubMed 12707146

  • 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.

    PubMed 25948900

  • 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.

    PubMed 15957691

  • 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.

    PubMed 28186223

  • 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.

    PubMed 12761468

  • 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.

    PubMed 37328611

  • 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.

    PubMed 33776087

  • 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.

    PubMed 29624026

Questions about this trial

What is this clinical trial studying?

A study testing stress ball in people with Anxiety, run by National Taiwan University Hospital at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate Variability (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06742814, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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Clinical Trial NCT06742814 | AzTrials