Cataract SurgeryNCT07108192
The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety
A study testing Hand Holding and Stress Ball in people with Cataract Surgery, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Cataract surgery is currently primarily performed with topical anesthesia. Although topical anesthesia provides many benefits for patients, they may experience pain, anxiety and discomfort during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Hand Holding and Stress Ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Oct 2025to 11 Mar 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
- 18 years and over
- Can understand and speak Turkish
- Clear consciousness, person, place and time oriented
- No hearing and perception problems
- Does not have any mental or neurological disorders that may affect communication (Alzheimer's, dementia, etc.)
- First time cataract surgery
Show all 10Show fewer
- Those without any psychiatric diagnosis/ treatment (antidepressants, anxiolytics, sedatives, etc.)
- No physical problems in squeezing the stress ball (muscle, joint problems, etc.)
- No analgesic or anesthetic medication 24 hours before the procedure
- Individuals who agree to participate in the study will be included in the study
Who cannot join
- Conversion of topical anesthesia to general anesthesia during surgery
- A different story of eye surgery
- Hearing, speech, physical or mental disability
- Pregnancy or possible pregnancy
- Those with malignancy
- Taking an analgesic medication at least 24 hours before the procedure
Show all 20Show fewer
- People with chronic pain
- History of incomplete or canceled cataract procedures
- Hypertension in the patient (>160/100 mmHg)
- Suppurative/infective/inflammatory skin condition of the hands
- Hypersensitivity to touch
- Patients with contact-transmitted diseases
- Being uncomfortable with hand-holding,
- In case of need for emergency intervention by a physician during or immediately after the procedure
- Failure to perform the stress ball application in accordance with the instruction
- Pre-existing neuropathy (muscle joint problem, stroke, etc.)
- Complications during cataract surgery
- Those who want to leave the study voluntarily
- Termination of the procedure due to deterioration of the patient's general condition during the procedure
- Failure to carry out intervention practices in accordance with the determined protocol (Dropping the stress ball during the procedure, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety During Cataract Surgery: A Randomized Controlled Trial
Cataract surgery is currently primarily performed with topical anesthesia. Although topical anesthesia provides many benefits for patients, they may experience pain, anxiety and discomfort during surgery. It has been reported that increased pain and anxiety during surgery may decrease patient cooperation and satisfaction, making surgery more difficult. In this context, in addition to medical interventions, non-pharmacologic methods are recommended to manage pain and anxiety during surgery. Non-pharmacological methods are reported to be simple, effective and cost-effective. In this context, studies have shown that stress ball application and hand holding are effective strategies for the control of pain and anxiety in patients.
According to this information, the aim of this study was to evaluate the effect of stress ball application and hand holding method used during cataract surgery on patients' pain and anxiety.
Another aim of the study was to determine the effects of stress ball application and hand holding method on patients' satisfaction levels and vital signs.
Read the detailed description
Cataract is the main cause of visual impairment and blindness globally and surgery remains the only effective treatment for cataract. Today, it is a common procedure for routine cataract surgery under topical anesthesia. Topical anesthesia is most commonly used because it eliminates potential complications such as optic nerve damage, retrobulbar hemorrhage and ocular muscle injury. However, topical anesthesia does not eliminate pain sensitivity of the iris, zonule and ciliary body during cataract surgery. Moreover, patients may experience discomfort due to manipulation of intraocular structures during surgery. However, patients are awake during surgery to follow the surgeon's instructions, which can lead to anxiety and adverse consequences in physiologic parameters such as tachycardia and hypertension. Patients may move during surgery due to anxiety and pain, and may lose visual function due to bleeding or post-surgical complications such as glaucoma. Therefore, assessing and controlling pain and anxiety during surgery is important for patient comfort and surgical prognosis. Moreover, the management of pain and anxiety during surgery not only reduces patients' anxiety but also increases patient cooperation during surgery. In this context, pharmacological as well as non-pharmacological methods are widely used in the management of pain and anxiety. Although the effects of hand holding and stress ball application on patients' pain, anxiety, satisfaction levels and vital signs in various contexts have been reported, their effects, especially during cataract surgery, have not been sufficiently investigated. Therefore, this study aims to contribute to the existing literature by examining the effects of hand holding and stress ball application on patients' pain, anxiety, satisfaction levels and vital signs during cataract and to provide evidence for the importance of the use of nonpharmacologic methods.
- Conditions
- Cataract Surgery
- Being tested
- Hand Holding, Stress Ball, Control Group
- Keywords
- hand holding, stress ball, pain, anxiety, cataract surgery
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand HoldingOther
Hand holding intervention will be performed by the researcher. Before cataract surgery, the researcher will sit in a chair next to the patient and warm his/her hands to a level that does not disturb the patient. 1-2 minutes before cataract surgery, the researcher will hold the patient's hand without gloves, with one hand, with moderate pressure, without rubbing or squeezing it uncomfortably. The hand holding intervention will continue until the cataract surgery is completed
Stress BallOther
According to the randomization, the patient in the stress ball group will first be taught the use of stress balls face to face by the researcher. The researcher will place a round, medium-hard, high-quality stress ball of the same brand in the patient's active hand 1-2 minutes before the cataract surgery is started. The patient will be asked to squeeze and relax the stress ball by counting to 5 during cataract surgery. After squeezing the stress ball, he/she should count to 5 and then loosen it. The patient will be asked to continue this process until the cataract surgery is completed.
Control GroupOther
Patients who did not receive any intervention other than standard treatment and care during cataract surgery were defined as the control group.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball | Experimental | Non-pharmacological methods are preferred because they are economical, carry minimal risk of complications and can be easily applied in clinical settings. In this context, the stress ball, a distraction method, is effective in providing cognitive focus. Stress ball intevention is reported to be effective on pain, anxiety, satisfaction levels and vital signs of patients. Receives: Other: Stress Ball |
| Hand Holding | Experimental | Touch is a critical nursing intervention that conveys empathy. Physical touch is reported to play an important role in calming the patient and showing interest in the patient. It is also reported that physical touch has positive effects on patients' pain, anxiety, satisfaction levels and vital signs. Hand holding is one of the methods of physical touch. Receives: Other: Hand Holding |
| Control Group | Active comparator | Patients do not undergo any additional intervention other than standard routine procedures Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety levels
Anxiety level of the patients will be evaluated with State Anxiety Inventory Short Version. The short form of the inventory was developed by Zsido and colleagues and adapted to the Turkish population. The form is a 4-point Likert-type inventory consisting of a total of 5 items. Individuals who score 10 and higher on the State Anxiety Inventory Short Version are considered clinically anxious.
Measured: Anxiety levels of the patients will be evaluated in 2 stages, 15 minutes before surgery and 15 minutes after the surgery is completed.
Pain levels
The pain level of the patients will be evaluated by Visual Analog Scale (VAS). Their values range from 0-10. Absence of pain is defined as "0 points" and unbearable pain is defined as "10 points".
Measured: Patients' pain levels will be evaluated in 2 stages: intraoperatively and 15 minutes after the operation is completed
Secondary outcomes (5)
Patient satisfaction level
The Visual Analog (VAS) is a valid and reliable tool for measuring subjective feelings such as mood. In this study, it will be used to assess patient satisfaction levels. Their values range from 0-10. High scores on the scale indicate high satisfaction (0=Not at all satisfied, 10=Very satisfied).
Measured: Patients' satisfaction levels will be assessed in a single stage 15 minutes after the operation is completed
Physiological parameters-blood pressure
systolic and diastolic blood pressure
Measured: Patients' blood pressure will be measured 15 minutes before surgery and 15 minutes after surgery is completed.
Physiological parameters-pulse rate
Pulse rate
Measured: The pulse rate of the patients will be measured 15 minutes before surgery and 15 minutes after surgery is completed.
Physiological parameters-respiratory rate
Respiratory rate
Measured: The respiratory rate of the patients will be measured 15 minutes before surgery and 15 minutes after surgery is completed.
Physiological parameters-oxygen saturation
Oxygen saturation
Measured: Oxygen saturation of the patients will be measured 15 minutes before surgery and 15 minutes after surgery is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start8 Oct 2025
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysel GUL, Sakarya University
- Investigators
- Aysel GÜL, Phd, Study director, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108192
- Sponsor's protocol ID
- E-43012747-050.04-489789-435
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is planned to be published after the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety During Cataract Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07108192
- Acronym / sponsor ID
- E-43012747-050.04-489789-435
- Conditions
- Cataract Surgery
- Keywords
- hand holding, stress ball, pain, anxiety, cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 6 Aug 2025 (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.
Cataract surgery is currently primarily performed with topical anesthesia. Although topical anesthesia provides many benefits for patients, they may experience pain, anxiety and discomfort during surgery. It has been reported that increased pain and anxiety during surgery may decrease patient cooperation and satisfaction, making surgery more difficult. In this context, in addition to medical interventions, non-pharmacologic methods are recommended to manage pain and anxiety during surgery. Non-pharmacological methods are reported to be simple, effective and cost-effective. In this context, studies have shown that stress ball application and hand holding are effective strategies for the control of pain and anxiety in patients.
According to this information, the aim of this study was to evaluate the effect of stress ball application and hand holding method used during cataract surgery on patients' pain and anxiety.
Another aim of the study was to determine the effects of stress ball application and hand holding method on patients' satisfaction levels and vital signs.
Detailed description
Cataract is the main cause of visual impairment and blindness globally and surgery remains the only effective treatment for cataract. Today, it is a common procedure for routine cataract surgery under topical anesthesia. Topical anesthesia is most commonly used because it eliminates potential complications such as optic nerve damage, retrobulbar hemorrhage and ocular muscle injury. However, topical anesthesia does not eliminate pain sensitivity of the iris, zonule and ciliary body during cataract surgery. Moreover, patients may experience discomfort due to manipulation of intraocular structures during surgery. However, patients are awake during surgery to follow the surgeon's instructions, which can lead to anxiety and adverse consequences in physiologic parameters such as tachycardia and hypertension. Patients may move during surgery due to anxiety and pain, and may lose visual function due to bleeding or post-surgical complications such as glaucoma. Therefore, assessing and controlling pain and anxiety during surgery is important for patient comfort and surgical prognosis. Moreover, the management of pain and anxiety during surgery not only reduces patients' anxiety but also increases patient cooperation during surgery. In this context, pharmacological as well as non-pharmacological methods are widely used in the management of pain and anxiety. Although the effects of hand holding and stress ball application on patients' pain, anxiety, satisfaction levels and vital signs in various contexts have been reported, their effects, especially during cataract surgery, have not been sufficiently investigated. Therefore, this study aims to contribute to the existing literature by examining the effects of hand holding and stress ball application on patients' pain, anxiety, satisfaction levels and vital signs during cataract and to provide evidence for the importance of the use of nonpharmacologic methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stress Ball | Experimental | Other: Stress BallNon-pharmacological methods are preferred because they are economical, carry minimal risk of complications and can be easily applied in clinical settings. In this context, the stress ball, a distraction method, is effective in providing cognitive focus. Stress ball intevention is reported to be effective on pain, anxiety, satisfaction levels and vital signs of patients. |
| Hand Holding | Experimental | Other: Hand HoldingTouch is a critical nursing intervention that conveys empathy. Physical touch is reported to play an important role in calming the patient and showing interest in the patient. It is also reported that physical touch has positive effects on patients' pain, anxiety, satisfaction levels and vital signs. Hand holding is one of the methods of physical touch. |
| Control Group | Active comparator | Other: Control GroupPatients do not undergo any additional intervention other than standard routine procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years and over
- Can understand and speak Turkish
- Clear consciousness, person, place and time oriented
- No hearing and perception problems
- Does not have any mental or neurological disorders that may affect communication (Alzheimer's, dementia, etc.)
Key exclusion criteria (20 listed)
- Conversion of topical anesthesia to general anesthesia during surgery
- A different story of eye surgery
- Hearing, speech, physical or mental disability
- Pregnancy or possible pregnancy
- Those with malignancy
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 |
|---|---|---|
| Hand HoldingHand holding intervention will be performed by the researcher. Before cataract surgery, the researcher will sit in a chair next to the patient and warm his/her hands to a level that does not disturb the patient. 1-2 minutes before cataract surgery, the researcher will hold the patient's hand without gloves, with one hand, with moderate pressure, without rubbing or squeezing it uncomfortably. The hand holding intervention will continue until the cataract surgery is completed | Other | Hand Holding |
| Stress BallAccording to the randomization, the patient in the stress ball group will first be taught the use of stress balls face to face by the researcher. The researcher will place a round, medium-hard, high-quality stress ball of the same brand in the patient's active hand 1-2 minutes before the cataract surgery is started. The patient will be asked to squeeze and relax the stress ball by counting to 5 during cataract surgery. After squeezing the stress ball, he/she should count to 5 and then loosen it. The patient will be asked to continue this process until the cataract surgery is completed. | Other | Stress Ball |
| Control GroupPatients who did not receive any intervention other than standard treatment and care during cataract surgery were defined as the control group. | Other | Control Group |
Primary outcome
Anxiety levels
Time frame: Anxiety levels of the patients will be evaluated in 2 stages, 15 minutes before surgery and 15 minutes after the surgery is completed.
Anxiety level of the patients will be evaluated with State Anxiety Inventory Short Version. The short form of the inventory was developed by Zsido and colleagues and adapted to the Turkish population. The form is a 4-point Likert-type inventory consisting of a total of 5 items. Individuals who score 10 and higher on the State Anxiety Inventory Short Version are considered clinically anxious.
Pain levels
Time frame: Patients' pain levels will be evaluated in 2 stages: intraoperatively and 15 minutes after the operation is completed
The pain level of the patients will be evaluated by Visual Analog Scale (VAS). Their values range from 0-10. Absence of pain is defined as "0 points" and unbearable pain is defined as "10 points".
5 secondary outcomes
Patient satisfaction level
Time frame: Patients' satisfaction levels will be assessed in a single stage 15 minutes after the operation is completed
Physiological parameters-blood pressure
Time frame: Patients' blood pressure will be measured 15 minutes before surgery and 15 minutes after surgery is completed.
Physiological parameters-pulse rate
Time frame: The pulse rate of the patients will be measured 15 minutes before surgery and 15 minutes after surgery is completed.
Physiological parameters-respiratory rate
Time frame: The respiratory rate of the patients will be measured 15 minutes before surgery and 15 minutes after surgery is completed.
Physiological parameters-oxygen saturation
Time frame: Oxygen saturation of the patients will be measured 15 minutes before surgery and 15 minutes after surgery is completed.
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 14 Oct 2026.
- Individual participant dataSharing planned: No. It is planned to be published after the study is 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.
Aysel GÜL, Phd study director
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Holding and Stress Ball in people with Cataract Surgery, run by Sakarya 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 10 inclusion and 20 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 14 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?
Anxiety levels (time frame: Anxiety levels of the patients will be evaluated in 2 stages, 15 minutes before surgery and 15 minutes after the surgery is completed.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.