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

ConditionCataract Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSakarya University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years and over

Can understand and speak Turkish

Clear consciousness, person, place and time oriented

No hearing and perception problems

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hand Holding

    Other intervention

    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 Ball

    Other intervention

    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 Group

    Other intervention

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

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: Stress BallExperimental treatment 1 intervention
Group B: Hand HoldingExperimental treatment 1 intervention
Group C: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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.
2

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".

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

Secondary outcomes

1

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).

Time frame
Patients' satisfaction levels will be assessed in a single stage 15 minutes after the operation is completed
2

Physiological parameters-blood pressure

systolic and diastolic blood pressure

Time frame
Patients' blood pressure will be measured 15 minutes before surgery and 15 minutes after surgery is completed.
3

Physiological parameters-pulse rate

Pulse rate

Time frame
The pulse rate of the patients will be measured 15 minutes before surgery and 15 minutes after surgery is completed.
4

Physiological parameters-respiratory rate

Respiratory rate

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sakarya University

Lead sponsor

Source ClinicalTrials.gov
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