Effects of Virtual Glasses, Stress Ball and Music Intervention on Pain, Anxiety and Comfort in Patients Undergoing Inguinal Hernia Surgery

May 1, 2025 updated by: Cagla Toprak

Effects of Virtual Glasses, Stress Ball and Music Intervention on Pain, Anxiety and Comfort in Patients Undergoing Inguinal Hernia Surgery: A Randomized Controlled Trial

Although it changes with age, due to its high incidence and prevalence, inguinal hernia is one of the most commonly performed surgeries by general surgeons. Pain, anxiety and changes in comfort levels in patients after inguinal hernia repair surgery negatively affect the patient's recovery after surgery. One of the goals of nursing care practices in the perioperative period, especially in patients undergoing surgery, is to provide and maintain patient comfort. Today, the concept of comfort is a part of quality nursing care, allowing patients to be comfortable, carefree, recover more quickly and cope better with disease stress. Using non-pharmacological methods in pain management reduces the use of pharmacological methods, increases the patient's comfort level, reduces stress and anxiety, increases the individual's sense of control over their own health and increases physical function and daily life activities. Virtual reality, music therapy, stress ball are used in various areas of clinical medical care as a way to distract attention and relieve pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aimed to evaluate the effects of distraction methods such as virtual reality, music therapy and stress ball applications on pain, anxiety and comfort levels in patients undergoing inguinal hernia surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between the ages of 18-70 Inguinal surgery will be performed,

    • No communication problems, can speak Turkish,
    • No psychiatric illness or mental perception problems,
    • No vision, hearing and perception problems,
    • No physical problems in squeezing a stress ball,

Exclusion Criteria:

  • • Any postoperative complications,

    • Patients who do not agree to participate in the study,
    • Patients using anxiolytic drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group
Patients in the control group will not undergo any intervention other than the standard care protocol.
Experimental: music group
The patient will be asked to choose their favorite music. The playlist will include ten songs from each music group (pop, Turkish classical music, local folk songs and religious music), for a total of 50 songs. The options will be shown to the patient via the phone (Apple/ MU783TU/A) and the music they want will be added to the playlist. The selected music will be listened to for 15 minutes before the surgery.
Other: Music intervention
The patient will be asked to choose their favorite music. The playlist will include ten songs from each music group (pop, Turkish classical music, local folk songs and religious music), a total of 50 songs. The options will be shown to the patient via the phone (Apple/ MU783TU/A) and the music they want will be added to the playlist. The selected music will be listened to for 15 minutes before the surgery.
Other: stres ball
Stress balls will be given to the patient in both palms, they will be asked to count from one to five and squeeze twice. The patient will be shown and made to use the stress balls for 15 minutes before the surgery. When the 15 minutes are up, the patient will be informed by the nurse and the patient will be asked to release the balls.
Other: Virtual Reality Glasses
The patient will be shown a video of a nature walk by the nurse providing nursing care to the patient. The patients will be shown a video with virtual reality glasses for 15 minutes before the surgery.
Experimental: stress ball
Stress balls will be given to the patient in both palms, and they will be asked to count from one to five and squeeze them twice. The patient will be shown how to use the stress balls for 15 minutes before the surgery and will be made to practice. When the 15 minutes are up, the nurse will inform the patient and have the patient put the balls down.
Other: Music intervention
The patient will be asked to choose their favorite music. The playlist will include ten songs from each music group (pop, Turkish classical music, local folk songs and religious music), a total of 50 songs. The options will be shown to the patient via the phone (Apple/ MU783TU/A) and the music they want will be added to the playlist. The selected music will be listened to for 15 minutes before the surgery.
Other: stres ball
Stress balls will be given to the patient in both palms, they will be asked to count from one to five and squeeze twice. The patient will be shown and made to use the stress balls for 15 minutes before the surgery. When the 15 minutes are up, the patient will be informed by the nurse and the patient will be asked to release the balls.
Other: Virtual Reality Glasses
The patient will be shown a video of a nature walk by the nurse providing nursing care to the patient. The patients will be shown a video with virtual reality glasses for 15 minutes before the surgery.
Experimental: virtual reality glasses
The patient will be shown a video of a nature walk by the nurse providing nursing care to the patient. The patients will be shown a video with virtual reality glasses for 15 minutes before the surgery.
Other: Music intervention
The patient will be asked to choose their favorite music. The playlist will include ten songs from each music group (pop, Turkish classical music, local folk songs and religious music), a total of 50 songs. The options will be shown to the patient via the phone (Apple/ MU783TU/A) and the music they want will be added to the playlist. The selected music will be listened to for 15 minutes before the surgery.
Other: stres ball
Stress balls will be given to the patient in both palms, they will be asked to count from one to five and squeeze twice. The patient will be shown and made to use the stress balls for 15 minutes before the surgery. When the 15 minutes are up, the patient will be informed by the nurse and the patient will be asked to release the balls.
Other: Virtual Reality Glasses
The patient will be shown a video of a nature walk by the nurse providing nursing care to the patient. The patients will be shown a video with virtual reality glasses for 15 minutes before the surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
comfort
Time Frame: 10 minutes before surgery stress.
t was designed by researchers similar to the use of "Visual Analog Scale (VAS)". VAS is used to make measurable some values that cannot be measured numerically, which are evaluated by individuals by marking on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end indicates that the individual is "very bad".
10 minutes before surgery stress.
pain assessment
Time Frame: 10 minutes before surgery pain
It was designed by researchers similar to the use of "Visual Analog Scale (VAS)". VAS is used to make measurable some values that cannot be measured numerically, which are evaluated by individuals by marking on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end indicates that the individual is "very bad".
10 minutes before surgery pain
anxiety
Time Frame: 10 minutes after surgery
This scale consists of two parts: STAI-I and STAI-II. The scale consists of 20 items. Items 1-20 on the scale measure anxiety in four options. Trait anxiety scores were calculated by adding the unchanging number 35 for the trait anxiety scale to the obtained result. The lowest score on the scale is 20, the highest score is 80. Score Status Anxiety level; 0-19 points indicate no anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, 60-79 points indicate severe anxiety, 80 and above indicate panic level anxiety. As the score increases, the anxiety level also increases.
10 minutes after surgery
comfort
Time Frame: Will be evaluated at 10 minutes and 24 hours after surgery
It was designed by researchers similar to the use of "Visual Analog Scale (VAS)". VAS is used to make measurable some values that cannot be measured numerically, which are evaluated by individuals by marking on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end indicates that the individual is "very bad".
Will be evaluated at 10 minutes and 24 hours after surgery
pain assesment
Time Frame: Will be evaluated at 10 minutes and 24 hours after surgery
It was designed by researchers similar to the use of "Visual Analog Scale (VAS)". VAS is used to make measurable some values that cannot be measured numerically, which are evaluated by individuals by marking on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end indicates that the individual is "very bad".
Will be evaluated at 10 minutes and 24 hours after surgery
anxiety
Time Frame: Will be evaluated at 10 minutes and 24 hours after surgery
this scale consists of two parts: STAI-I and STAI-II. The scale consists of 20 items. Items 1-20 on the scale measure anxiety in four options. Trait anxiety scores were calculated by adding the unchanging number 35 for the trait anxiety scale to the obtained result. The lowest score on the scale is 20, the highest score is 80. Score Status Anxiety level; 0-19 points indicate no anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, 60-79 points indicate severe anxiety, 80 and above indicate panic level anxiety. As the score increases, the anxiety level also increases.
Will be evaluated at 10 minutes and 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cagla Toprak

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23.12.2024- 10/40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings