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

NCT ID: NCT06742814

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety

Keywords

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anxiety stress ball ambulatory surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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control group

usal nursing care

Group Type NO_INTERVENTION

No interventions assigned to this group

intervation group

stress ball

Group Type EXPERIMENTAL

stress ball

Intervention Type DEVICE

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

Interventions

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stress ball

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- 1. Those who are over 18 years old, have clear consciousness and can communicate in Chinese and Taiwanese Hakka.

2\. Patients undergoing outpatient surgery under local anesthesia.

Exclusion Criteria

* Unable to cooperate
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hsueh-Ling Chang

Role: STUDY_CHAIR

NTUH Hsin-Chu Branch

Central Contacts

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Hsueh-Ling Chang

Role: CONTACT

Phone: 886- 3- 5326151

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 25239073 (View on PubMed)

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.

Reference Type RESULT
PMID: 19583663 (View on PubMed)

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.

Reference Type RESULT
PMID: 25641687 (View on PubMed)

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.

Reference Type RESULT
PMID: 37199436 (View on PubMed)

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.

Reference Type RESULT
PMID: 10875713 (View on PubMed)

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.

Reference Type RESULT
PMID: 12707146 (View on PubMed)

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.

Reference Type RESULT
PMID: 25948900 (View on PubMed)

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.

Reference Type RESULT
PMID: 15957691 (View on PubMed)

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.

Reference Type RESULT
PMID: 28186223 (View on PubMed)

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.

Reference Type RESULT
PMID: 12761468 (View on PubMed)

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.

Reference Type RESULT
PMID: 37328611 (View on PubMed)

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.

Reference Type RESULT
PMID: 33776087 (View on PubMed)

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.

Reference Type RESULT
PMID: 29624026 (View on PubMed)

Related Links

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https://doi.org/10.1016/j.ijso.2020.05.010

Global prevalence and determinants of preoperative anxiety among surgical patients: A systematic review and meta-analysis

https://doi.org/10.33448/rsd-v10i8.17237

Influence of anxiety on the heart rate variability of patients in preoperative orthopedic surgery

Other Identifiers

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202408018RIND

Identifier Type: -

Identifier Source: org_study_id