Stress Ball Use During Cataract Surgery: Effects on Pain, Fear and Satisfaction

NCT07452770 | Recruiting

• 1 other identifier: BDEMİRCAN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of stress ball use during cataract surgery on patients' pain, fear, and satisfaction levels.

Conditions

Cataract Surgery; Pain; Fear; Stress Ball; Nursing

Keywords

pain management; Surgical fear; nursing; cataract surgery; satisfaction

Outcome Measures

Primary Outcomes (4)

• Patient Information Form

  Prepared by researchers based on a review of similar studies on the subject in the literature. The form contains six (6) questions regarding the socio-demographic characteristics of patients who have undergone cataract surgery, including age, marital status, educational status, employment status, and economic status; and six (6) questions regarding the presence of chronic diseases, regular medication use, smoking/alcohol consumption, previous hospitalizations, and previous cataract surgeries, for a total of 12 questions.

  Time point 1: preoperatively (immediately before surgery)

• Visual Analogue Scale (VAS)

  First defined in 1921 and used to assess patients' subjective pain levels, the VAS is a form consisting of a horizontal line 10 cm long. The leftmost part of this measurement tool indicates "no pain," while the rightmost part indicates "unbearable pain." A high score on the scale indicates severe pain, while a low score indicates mild pain. The scale is scored as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.

  Time point 1: preoperatively (immediately before surgery) Time point 2: intraoperatively Time point 3: immediately postoperatively

• Surgical Fear Questionnaire (SFQ)

  Developed by Theunissen et al. (2014), this scale consists of 8 items and aims to assess the long- and short-term levels of anxiety experienced by patients scheduled for elective surgery. The Turkish validity and reliability study was conducted by Bağdigen and Karaman Özlü in 2016. The scale consists of 11 Likert-type items, a total of eight items, and two subscales: fear of the short-term and long-term outcomes of surgery. Items 1 to 4 inquire about the short-term outcomes of surgery, while items 5 to 8 inquire about the long-term outcomes.The Cronbach's alpha coefficient for the CKÖ total score was found to be 0.934, for the CKÖ-Short-term fears subscale 0.960, and for the CKÖ-Long-term fears subscale 0.907. As the scale score increases, the patients' level of surgical fear increases.

  Time point 1: preoperatively (immediately before surgery) Time point 2: intraoperatively Time point 3: immediately postoperatively

• Visual Comparison Scale for Satisfaction

  In this scale, satisfaction levels are determined by scoring between 0 and 10. A score of "0" represents the lowest level of satisfaction, while a score of "10" represents the highest level of satisfaction. Patients are asked to indicate the level of their pain on a scale from 0 to 10, with the numerical value representing the patient's satisfaction level.

  Time point 1: intraoperatively Time point 2: immediately postoperatively

Study Arms (2)

Experimental group: the group using a stress ball

EXPERIMENTAL

Patients who used a stress ball during cataract surgery

Other: Use of a stress ball during cataract surgery

Control group: Patients who did not use a stress ball

NO INTERVENTION

Patients who received standard care without using a stress ball during cataract surgery

Interventions

Use of a stress ball during cataract surgery OTHER

To examine the effect of using a stress ball, a non-pharmacological method, during scheduled cataract surgery on patients' pain, surgical fear, and satisfaction levels.

Experimental group: the group using a stress ball

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 years or older,
• Without hearing or cognitive impairments,
• Without any neurological conditions that would prevent squeezing a stress ball,
• Without any physical limitations in the hands or arms that would prevent squeezing a stress ball,
• Individuals undergoing cataract surgery for the first time will be included.

You may not qualify if:

• Under 18 years of age,
• Change in anesthesia type during surgery (from topical anesthesia to general anesthesia)
• Patients scheduled for cataract surgery under general anesthesia,
• Patients with psychiatric disorders,
• Patients diagnosed with uncontrolled hypertension,
• Patients who used any analgesic or anxiolytic prior to surgery will not be included in the study.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Istanbul, 34065, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Zeng K, Li Q, Xi W, Qiao Y. Measures to improve the comfort of cataract surgery patients: a systematic review and meta-analysis. Ann Palliat Med. 2021 Nov;10(11):11849-11858. doi: 10.21037/apm-21-2945.

  PMID: 34872309 RESULT

• Jiang L, Zhang K, He W, Zhu X, Zhou P, Lu Y. Perceived Pain during Cataract Surgery with Topical Anesthesia: A Comparison between First-Eye and Second-Eye Surgery. J Ophthalmol. 2015;2015:383456. doi: 10.1155/2015/383456. Epub 2015 May 4.

  PMID: 26064671 RESULT

• Obuchowska I, Konopinska J. Fear and Anxiety Associated with Cataract Surgery Under Local Anesthesia in Adults: A Systematic Review. Psychol Res Behav Manag. 2021 Jun 18;14:781-793. doi: 10.2147/PRBM.S314214. eCollection 2021.

  PMID: 34177276 RESULT

• Dastan N, Sezer Efe Y, Erkilic K. The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters. J Perianesth Nurs. 2024 Oct;39(5):831-838. doi: 10.1016/j.jopan.2023.12.018. Epub 2024 May 22.

  PMID: 38775768 RESULT

• Socea SD, Abualhasan H, Magen O, Zayit-Soudry S, Blumenthal EZ, Duvdevan N, Mimouni M. Preoperative Anxiety Levels and Pain during Cataract Surgery. Curr Eye Res. 2020 Apr;45(4):471-476. doi: 10.1080/02713683.2019.1666996. Epub 2019 Sep 18.

  PMID: 31509020 RESULT

• Yenigun SC, Demir Korkmaz F. The Effects of Stress Ball Practice on Patient Anxiety, Pain and Vital Signs During Cataract Surgery: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Oct;26(5):592-599. doi: 10.1016/j.pmn.2025.04.009. Epub 2025 May 20.

  PMID: 40399154 RESULT

MeSH Terms

Conditions

Pain; Agnosia; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Behavior

Central Study Contacts

Burcu DEMİRCAN BDEMİRCAN, PhD

CONTACT

+905072325511; bdemircan@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 5, 2026
• Study Start: September 1, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)