Hand holding and stress ball to reduce pain and anxiety during cataract surgery
The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety During Cataract Surgery: A Randomized Controlled Trial
This study will test whether holding a hand or squeezing a stress ball reduces pain and anxiety for adults having cataract surgery with topical anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sakarya University Academic / other |
| Locations | 1 site (Sakarya) |
| Trial ID | NCT07108192 on ClinicalTrials.gov |
What this trial studies
Adults having routine cataract surgery under topical anesthesia are assigned to receive either hand holding, a stress ball to squeeze, or usual care during the operation. Pain and anxiety levels will be measured before, during, and after the procedure using standard scales, and vital signs and patient satisfaction will be recorded. The interventions are non-pharmacologic, simple, and low-cost, and are applied during the surgical visit at the clinic. Outcomes will compare whether these supportive measures improve comfort and cooperation compared with control.
Who should consider this trial
Good fit: Adults (18+) scheduled for their first cataract surgery under topical anesthesia who speak Turkish, are cognitively and physically able to participate, are not taking sedatives/analgesics, and can squeeze a stress ball are ideal candidates.
Not a fit: Patients receiving general anesthesia, those with recent analgesic or chronic pain conditions, cognitive impairment, or who cannot squeeze a ball are unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, these simple, low-cost methods could reduce pain and anxiety during cataract surgery and improve patient comfort and cooperation.
How similar studies have performed: Previous studies have reported that hand holding and stress ball use can reduce pain and anxiety in surgical and procedural settings, supporting this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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.)
Where this trial is running
Sakarya
- Yenikent State Hospital — Sakarya, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Aysel GÜL
- Email: ayselgul@sakarya.edu.tr
- Phone: +90 539 567 66 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.