PainNCT06964984
Effects of Virtual Glasses, Stress Ball and Music Intervention on Pain, Anxiety and Comfort in Patients Undergoing Inguinal Hernia Surgery
A study testing Music intervention, stres ball and Virtual Reality Glasses in people with Pain and Anxiety, run by Cagla Toprak.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Anxiety, Inguinal Hernia
- What is being tested?
- Music intervention, stres ball and Virtual Reality Glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- • Any postoperative complications,
- Patients who do not agree to participate in the study,
- Patients using anxiolytic drugs
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Pain, Anxiety, Inguinal Hernia
- Being tested
- Music intervention, stres ball, Virtual Reality Glasses
- Keywords
- inguinal hernia,virtual reality,stress ball,music therapy
- Medical subject headings
- Pain, Anxiety Disorders, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
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.
stres ballOther
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.
Virtual Reality GlassesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Music intervention; Other: stres ball; Other: 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. Receives: Other: Music intervention; Other: stres ball; Other: 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. Receives: Other: Music intervention; Other: stres ball; Other: Virtual Reality Glasses |
| control group | No intervention | Patients in the control group will not undergo any intervention other than the standard care protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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.
Measured: Will be evaluated at 10 minutes and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start5 Jun 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cagla Toprak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cagla Toprak, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964984
- Sponsor's protocol ID
- 23.12.2024- 10/40
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Glasses, Stress Ball and Music Intervention on Pain, Anxiety and Comfort in Patients Undergoing Inguinal Hernia Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06964984
- Acronym / sponsor ID
- 23.12.2024- 10/40
- Conditions
- Pain, Anxiety, Inguinal Hernia
- Keywords
- inguinal hernia,virtual reality,stress ball,music therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cagla ToprakUniversity, hospital or other
- Study start
- 5 Jun 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| music group | Experimental | Other: Music intervention, Other: stres ball, Other: Virtual Reality GlassesThe 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. |
| stress ball | Experimental | Other: Music intervention, Other: stres ball, Other: Virtual Reality GlassesStress 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. |
| virtual reality glasses | Experimental | Other: Music intervention, Other: stres ball, Other: Virtual Reality GlassesThe 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. |
| control group | No intervention | –Patients in the control group will not undergo any intervention other than the standard care protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between the ages of 18-70 Inguinal surgery will be performed,
Key exclusion criteria (3 listed)
- • Any postoperative complications,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionThe 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 | music group, stress ball, virtual reality glasses |
| stres ballStress 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 | music group, stress ball, virtual reality glasses |
| Virtual Reality GlassesThe 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 group, stress ball, virtual reality glasses |
Primary outcome
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".
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".
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.
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".
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".
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Background: PubMed 37278621Dogan 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.
- The Effect of Virtual Reality on Pain and Anxiety During Colonoscopy: A Randomized Controlled TrialLink provided by the sponsor.
- The Effect of Virtual Reality on Pain Experienced by School-Age Children During Venipuncture: A Randomized Controlled StudyLink provided by the sponsor.
- Use of virtual reality in managing paediatric procedural pain and anxiety: An integrative literature reviewLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention, stres ball and Virtual Reality Glasses in people with Pain and Anxiety, run by Cagla Toprak.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact çağla toprak (532 799 78 14, caykinn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comfort (time frame: 10 minutes before surgery stress.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06964984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.