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NCT Number: NCT07452770

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, 34065, Turkey (Türkiye)

Location status: Recruiting

Location contact

Burcu Demircan BDEMİRCAN, PhD

CONTACT

[email protected]

+905072325511

About this study

Cataract is a condition in which the normally transparent lens of the eye or its capsule (the transparent membrane surrounding the lens) becomes cloudy or opaque, blocking the passage of light from the lens to the retina. Cataract disease, which increases with age, is a major cause of vision loss worldwide, especially in individuals aged 40 and older. Risk factors for cataracts include age, diabetes, smoking, and prolonged exposure to sunlight. Except for galactosemic cataracts, surgical intervention is the only effective treatment for cataracts. Cataract surgeries (phacoemulsification) were initially performed under general anesthesia or regional block, but today they are primarily performed using topical anesthesia. Patients who undergo topical anesthesia may experience fear and anxiety due to the unfamiliarity of the operating room environment and the fact that they are conscious. The main reasons for these feelings are the fear that the surgery will be painful, that it will fail, that vision will deteriorate, or that vision will be completely lost. Patients may also experience fear of moving their head or eyes during surgery, coughing, or being unable to cooperate with the surgeon. Studies indicate that patients who undergo surgery with a high level of fear also experience a higher level of pain after surgery. Pain can increase the difficulty of the surgery and result in complications by reducing patients' willingness to cooperate during surgery and their satisfaction with the surgery. Pain management during cataract surgery not only reduces pain and anxiety but also improves cooperation with the patient during the procedure. For this reason, it is emphasized that providing pain management during cataract surgery is particularly important. Today, non-pharmacological methods are used alongside pharmacological methods to control the pain, stress, and fear experienced by patients during the intraoperative process. Non-pharmacological methods are effective in reducing preoperative anxiety, fear of surgery, and anticipated pain. There are many non-pharmacological methods (stress balls, aromatherapy, music therapy, hand massage, virtual reality glasses, etc.) used to reduce patients' fears and ensure their comfort during surgery, and one of the important methods is the use of stress balls. Stress balls are an effective method for distracting patients because they are accessible and inexpensive. Stress balls are an effective distraction method for patients due to their accessibility and low cost. Evidence from previous studies suggests that using stress balls during medical procedures, such as cataract surgery and endoscopy, may help reduce patients' pain levels and increase their satisfaction. Knowledge about the effect of emotional factors such as pain perception and fear on the course of cataract surgery and their effects on the healing process of the eye is of great importance. When effective methods are applied to eliminate or reduce the effect of these factors, both the success of the surgery and the patient's satisfaction and quality of life can be improved.

Therefore, the study was designed to determine the effect of using a stress ball, a non-pharmacological method, during cataract surgery on patients' pain, fear, and satisfaction levels. The sample size of the study was calculated using G*Power 3.1.9.7 based on the data from a similar study in the literature14, using a t-test for the difference between two independent means, with 0.80 power, 95% confidence (1-α), an effect size of f=0.66, and a one-tailed hypothesis assumption.The minimum sample size was calculated to be 60. The following will be used to collect data: "Patient Information Form," "Visual Analogue Scale (VAS)," "Visual Comparison Scale for Satisfaction," and "Surgical Fear Questionnaire". Data will be analyzed using the IBM SPSS Statistics 29.0 software package, and statistical significance will be assessed at the p<0.05 level.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Patient Information Form

    Time frame: Time point 1: preoperatively (immediately before surgery)

    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.

  2. Visual Analogue Scale (VAS)

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

    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.

  3. Surgical Fear Questionnaire (SFQ)

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

    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.

  4. Visual Comparison Scale for Satisfaction

    Time frame: Time point 1: intraoperatively Time point 2: immediately postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Burcu DEMİRCAN BDEMİRCAN, PhD

CONTACT

[email protected]

+905072325511

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

The Effect of Stress Ball Use on Patients' Pain, Fear and Satisfication" During Cataract Surgery

Acronym: SBUDCS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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