NCT06964984

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable pain

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

June 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 11, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 4, 2025

Last Update Submit

May 1, 2025

Conditions

Keywords

inguinal hernia,virtual reality,stress ball,music therapy

Outcome Measures

Primary Outcomes (6)

  • comfort

    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

    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

    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

    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

    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

    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

Study Arms (4)

music group

EXPERIMENTAL

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 interventionOther: stres ballOther: Virtual Reality Glasses

stress ball

EXPERIMENTAL

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 interventionOther: stres ballOther: Virtual Reality Glasses

virtual reality glasses

EXPERIMENTAL

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 interventionOther: stres ballOther: Virtual Reality Glasses

control group

NO INTERVENTION

Patients in the control group will not undergo any intervention other than the standard care protocol.

Interventions

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.

music groupstress ballvirtual reality glasses

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.

music groupstress ballvirtual 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.

music groupstress ballvirtual reality glasses

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Dogan Yilmaz E, Unlusoy Dincer N. The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):318-328. doi: 10.1097/SGA.0000000000000733. Epub 2023 Jun 5.

    PMID: 37278621BACKGROUND

Related Links

MeSH Terms

Conditions

PainAnxiety DisordersHernia, Inguinal

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersHernia, AbdominalHerniaPathological Conditions, Anatomical

Central Study Contacts

çağla toprak

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 4, 2025

First Posted

May 11, 2025

Study Start

June 5, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

May 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share