PainSBUDCSNCT07452770
Stress Ball Use During Cataract Surgery: Effects on Pain, Fear and Satisfaction
A study testing Use of a stress ball during cataract surgery in people with Pain and Fear, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Fear, Stress Ball
- What is being tested?
- Use of a stress ball during cataract surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 15 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Istanbul, 34065
About this study
Official title: The Effect of Stress Ball Use on Patients' Pain, Fear and Satisfication" During Cataract Surgery
The aim of this study is to determine the effect of stress ball use during cataract surgery on patients' pain, fear, and satisfaction levels.
Read the detailed description
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.
- Conditions
- Pain, Fear, Stress Ball, Nursing, Cataract Surgery
- Being tested
- Use of a stress ball during cataract surgery
- Keywords
- pain management, Surgical fear, nursing, cataract surgery, satisfaction
- Medical subject headings
- Pain, Agnosia, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a stress ball during cataract surgeryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: the group using a stress ball | Experimental | Patients who used a stress ball during cataract surgery Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Time point 1: intraoperatively Time point 2: immediately postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Sep 2025
- Primary completion15 Apr 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Demircan, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452770
- Sponsor's protocol ID
- BDEMİRCAN
- Acronym
- SBUDCS
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the data collection process is ongoing and has not yet been completed.
Publications
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.
PubMed 34872309Jiang 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.
PubMed 26064671Obuchowska 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.
PubMed 34177276Dastan 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.
PubMed 38775768Socea 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.
PubMed 31509020Yenigun 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.
PubMed 40399154
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Use on Patients' Pain, Fear and Satisfication" During Cataract Surgery
- ClinicalTrials.gov ID
- NCT07452770
- Acronym / sponsor ID
- SBUDCS / BDEMİRCAN
- Conditions
- Pain, Fear, Stress Ball, Nursing, Cataract Surgery
- Keywords
- pain management, Surgical fear, nursing, cataract surgery, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effect of stress ball use during cataract surgery on patients' pain, fear, and satisfaction levels.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group: the group using a stress ball | Experimental | Other: Use of a stress ball during cataract surgeryPatients who used 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of a stress ball during cataract surgeryTo examine the effect of using a stress ball, a non-pharmacological method, during scheduled cataract surgery on patients' pain, surgical fear, and satisfaction levels. | Other | Experimental group: the group using a stress ball |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Results publication: PubMed 34872309Zeng 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.
- Results publication: PubMed 26064671Jiang 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.
- Results publication: PubMed 34177276Obuchowska 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.
- Results publication: PubMed 38775768Dastan 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.
- Results publication: PubMed 31509020Socea 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.
- Results publication: PubMed 40399154Yenigun 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.
- Individual participant dataSharing planned: No. Because the data collection process is ongoing and has not yet been completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of a stress ball during cataract surgery in people with Pain and Fear, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Patient Information Form (time frame: Time point 1: preoperatively (immediately before surgery)). The study lists 4 primary outcomes in all. 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 NCT07452770, which also lists 6 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 8 Oct 2026.