ClinicalTrials.gg
Not yet recruitingNCT06964984Updated May 11, 2025

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

An interventional study of Music intervention and stres ball in Pain, Anxiety and Inguinal Hernia, sponsored by Cagla Toprak. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-11.

Sponsored by Cagla Toprak · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Pain
  • Anxiety
  • Inguinal Hernia

Keywords

  • inguinal hernia,virtual reality,stress ball,music therapy
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In context

Pain

10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.

This study's planned enrollment of 120 is above the median of 66 across 8,497 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Cagla Toprak is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

    • Any postoperative complications,

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • 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 · Other: stres ball · Other: Virtual Reality Glasses

  • 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 · Other: stres ball · Other: Virtual Reality Glasses

  • 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 · Other: stres ball · Other: Virtual Reality Glasses

  • No intervention
    control group

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

Interventions

  • OtherMusic 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.

  • Otherstres 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.

  • OtherVirtual 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.

06

What researchers measure

Primary outcomes

  1. 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".

    Time frame: 10 minutes before surgery stress.

  2. 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".

    Time frame: 10 minutes before surgery pain

  3. 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.

    Time frame: 10 minutes after surgery

  4. 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".

    Time frame: Will be evaluated at 10 minutes and 24 hours after surgery

  5. 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".

    Time frame: Will be evaluated at 10 minutes and 24 hours after surgery

  6. 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.

    Time frame: Will be evaluated at 10 minutes and 24 hours after surgery

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 37278621 ↗

Individual participant data

Plan to share: Yes

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2025; primary completion for Aug 2025, 1 month later.

Of 3,734 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 1 month is below that.

Counting every sponsor, half of 3,833 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2025
First posted
May 11, 2025
StartEst.
Jun 5, 2025
Primary completionEst.
Aug 1, 2025
CompletionEst.
Aug 1, 2025
Last update
May 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06964984
Lead sponsor
Cagla Toprak
Responsible party
Cagla Toprak (Dr., Atlas University) — Sponsor-investigator
First posted
May 11, 2025
Start date
Jun 5, 2025 (estimated)
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
May 11, 2025

Study contacts

çağla toprak
Contact
caykinn@gmail.com
532 799 78 14

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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