The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety

NCT07108192 | Recruiting

• 1 other identifier: E-43012747-050.04-489789-435
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cataract Surgery

Keywords

hand holding; stress ball; pain; anxiety; cataract surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  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".

  Patients' pain levels will be evaluated in 2 stages: intraoperatively and 15 minutes after the operation is completed

Secondary Outcomes (5)

• Patient satisfaction level

  Patients' satisfaction levels will be assessed in a single stage 15 minutes after the operation is completed

• Physiological parameters-blood pressure

  Patients' blood pressure will be measured 15 minutes before surgery and 15 minutes after surgery is completed.

• Physiological parameters-pulse rate

  The pulse rate of the patients will be measured 15 minutes before surgery and 15 minutes after surgery is completed.

• Physiological parameters-respiratory rate

  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 of the patients will be measured 15 minutes before surgery and 15 minutes after surgery is completed.

Study Arms (3)

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.

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.

Other: Hand Holding

Control Group

ACTIVE COMPARATOR

Patients do not undergo any additional intervention other than standard routine procedures

Other: Control Group

Interventions

Hand Holding OTHER

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

Hand Holding

Stress Ball OTHER

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.

Stress Ball

Control Group OTHER

Patients who did not receive any intervention other than standard treatment and care during cataract surgery were defined as the control group.

Control Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Yenikent State Hospital

Sakarya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Aysel GÜL, Phd

  Sakarya University

  STUDY DIRECTOR

Central Study Contacts

Aysel GÜL

CONTACT

+90 539 567 66 71; ayselgul@sakarya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 6, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)