Hernia SurgeryNCT07150936
Effect of Stress Ball Intervention on Psychophysiological Responses During Hernia Surgery: A Randomized Controlled Trial
A study testing stress ball application in people with Hernia Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of the stress ball applied during hernia surgery on the anxiety level, pain severity and vital signs of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia Surgery
- What is being tested?
- stress ball application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 30 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older,
- Willing to undergo surgery for an umbilical hernia, inguinal hernia, or femoral hernia,
- Have no hearing or perception problems,
- Have no physical disability that would prevent the use of a stress ball,
- Be undergoing hernia surgery for the first time.
Who cannot join
- Having used analgesic or anxiolytic medication before surgery,
- Being switched to general anesthesia during surgery despite planning for local anesthesia,
- Having a diagnosed psychiatric disorder,
- Being diagnosed with uncontrolled hypertension.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afsin State Hospital
Kahramanmaraş, Afşin, 46500
About this study
The aim of this study is to evaluate the effect of the stress ball applied during hernia surgery on the anxiety level, pain severity and vital signs of patients.
Read the detailed description
Hernia surgery is a common procedure aimed at repairing hernias that develop in the abdominal and groin walls. Postoperative pain in repairs performed with synthetic mesh poses a significant problem, depending on surgical technique and individual factors. Preoperative pain level, psychological sensitivity, and previous surgical experience can influence the severity and duration of pain. Preoperative anxiety can trigger physiological and neuroendocrine responses, leading to intraoperative and postoperative complications, increased analgesic requirements, and decreased patient satisfaction. Nonpharmacological methods are recommended in addition to pharmacological treatments for acute pain management.These approaches not only reduce anxiety but also strengthen patient collaboration. One such method, the use of a stress ball, reduces pain and anxiety, increasing patient comfort. The literature indicates that stress balls reduce anxiety and stress levels, increase patient satisfaction, and positively impact vital signs. However, randomized controlled trials examining these effects in hernia surgery are limited. This research is expected to offer unique contributions to the applicability of nonpharmacological approaches in surgery.
- Conditions
- Hernia Surgery
- Being tested
- stress ball application
- Keywords
- hernia surgery, stress ball, pain, Psychophysiological Response
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ball applicationBehavioural
Participants' demographic information will be collected interview using the Patient Information Form. Approximately 30 minutes before surgery, patients' systolic and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded. Pain severity will also be assessed using the VAS, and anxiety levels will be assessed using the VAS-A and Spielberger Trait Anxiety Scale. Intraoperative Period: All patients will be placed in the supine position on the operating room table. Patients in the intervention group will continue to use the stress ball for 15 minutes during the surgery, as per randomization. All patients will undergo a repeat 15-minute postoperative assessment of vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation), pain with a VAS, and anxiety levels with a VAS-A. After the patients are taken to the clinic after the surgery, the same physiological measurements will repeated 10 mnt later
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Participants' demographic information will be collected interview using the Patient Information Form. Approximately 30 minutes before surgery, patients' systolic and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded. Pain severity will also be assessed using the VAS, and anxiety levels will be assessed using the VAS-A and Spielberger Trait Anxiety Scale.
Intraoperative Period: All patients will be placed in the supine position on the operating room table. Patients in the intervention group will continue to use the stress ball for 15 minutes during the surgery, as per randomization. All patients will undergo a repeat 15-minute postoperative assessment of vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation), pain with a VAS, and anxiety levels with a VAS-A.
After the patients are taken to the clinic after the surgery, the same physiological measurements will repeated 10 mnt later Receives: Behavioral: stress ball application |
| no intervention group | No intervention | Patients in the control group will only be treated with the clinic's current standard care protocol. Individuals in this group will not receive any additional interventions or stress ball applications. Measurements will be taken at the same timeframes and using the same methods as patients in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spielberger State-Trait Anxiety Inventory
Developed by Spielberger and colleagues in 1970, this scale consists of two 20-item sections: the State Anxiety Inventory (STAI-I) and the Trait Anxiety Inventory (STAI-II). When assessing state anxiety, participants are asked to select one of the following options: "not at all," "a little," "a lot," or "completely." On the trait anxiety scale, responses are given as "almost never," "sometimes," "most of the time," or "most of the time." The scale's score ranges from 20 to 80, with higher scores indicating higher anxiety levels. In this study, the STAI-II scale will be administered preoperatively to assess patients' general anxiety levels and to identify differences in trait anxiety between groups.
Measured: 5 months
Visual Anxiety Scale (VAS-A)
The Visual Anxiety Scale (VAS-A) is a simple, single-question measurement tool developed to assess individuals' anxiety levels. This method, long used in psychological analyses, is now widely used to assess pain, quality of life, and mood. The scale features a 10-centimeter horizontal line labeled "No anxiety" and "Very high anxiety." Patients mark the point on this line corresponding to their perceived anxiety level, and the distance between these marks is measured in millimeters to score the point. A higher measurement indicates a higher anxiety level. Despite its short length, the VAS-A is a tool with proven validity and reliability.
Measured: 5 months
Visual Pain Scale (VAS)
Visual Pain Scale (VAS): The Visual Pain Scale (VAS) is a 10-cm-long line that can be applied horizontally or vertically to measure the level of pain experienced by an individual. The left end of the line is designated as "no pain," and the right end as "unbearable pain." The location of the point marked by the patient numerically reflects the intensity of the pain; the higher the score, the greater the perceived pain.
Measured: 5 months
Vital Signs Monitoring Form
Vital Signs Monitoring Form: The Vital Signs Monitoring Form was developed based on a literature review to monitor the physiological parameters of patients undergoing hernia surgery. The form regularly records heart rate, systolic and diastolic blood pressure, respiratory rate, and oxygen saturation before, during, and after surgery. This allows for objective assessment of patients' hemodynamic status. Additionally, a Visual Pain Scale is included to measure pain levels.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start15 Aug 2025
- Primary completion15 Aug 2025
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia SurgeryStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 groups: control and intervention group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muaz Gulsen, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150936
- Sponsor's protocol ID
- CU-SBF-CB-06
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stress Ball Intervention on Psychophysiological Responses During Hernia Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07150936
- Acronym / sponsor ID
- CU-SBF-CB-06
- Conditions
- Hernia Surgery
- Keywords
- hernia surgery, stress ball, pain, Psychophysiological Response
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 2 Sep 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.
The aim of this study is to evaluate the effect of the stress ball applied during hernia surgery on the anxiety level, pain severity and vital signs of patients.
Detailed description
Hernia surgery is a common procedure aimed at repairing hernias that develop in the abdominal and groin walls. Postoperative pain in repairs performed with synthetic mesh poses a significant problem, depending on surgical technique and individual factors. Preoperative pain level, psychological sensitivity, and previous surgical experience can influence the severity and duration of pain. Preoperative anxiety can trigger physiological and neuroendocrine responses, leading to intraoperative and postoperative complications, increased analgesic requirements, and decreased patient satisfaction. Nonpharmacological methods are recommended in addition to pharmacological treatments for acute pain management.These approaches not only reduce anxiety but also strengthen patient collaboration. One such method, the use of a stress ball, reduces pain and anxiety, increasing patient comfort. The literature indicates that stress balls reduce anxiety and stress levels, increase patient satisfaction, and positively impact vital signs. However, randomized controlled trials examining these effects in hernia surgery are limited. This research is expected to offer unique contributions to the applicability of nonpharmacological approaches in surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are 2 groups: control and intervention group
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: stress ball applicationParticipants' demographic information will be collected interview using the Patient Information Form. Approximately 30 minutes before surgery, patients' systolic and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded. Pain severity will also be assessed using the VAS, and anxiety levels will be assessed using the VAS-A and Spielberger Trait Anxiety Scale. Intraoperative Period: All patients will be placed in the supine position on the operating room table. Patients in the intervention group will continue to use the stress ball for 15 minutes during the surgery, as per randomization. All patients will undergo a repeat 15-minute postoperative assessment of vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation), pain with a VAS, and anxiety levels with a VAS-A. After the patients are taken to the clinic after the surgery, the same physiological measurements will repeated 10 mnt later |
| no intervention group | No intervention | –Patients in the control group will only be treated with the clinic's current standard care protocol. Individuals in this group will not receive any additional interventions or stress ball applications. Measurements will be taken at the same timeframes and using the same methods as patients in the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 18 years of age or older,
- Willing to undergo surgery for an umbilical hernia, inguinal hernia, or femoral hernia,
- Have no hearing or perception problems,
- Have no physical disability that would prevent the use of a stress ball,
- Be undergoing hernia surgery for the first time.
Key exclusion criteria (4 listed)
- Having used analgesic or anxiolytic medication before surgery,
- Being switched to general anesthesia during surgery despite planning for local anesthesia,
- Having a diagnosed psychiatric disorder,
- Being diagnosed with uncontrolled hypertension.
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 |
|---|---|---|
| stress ball applicationParticipants' demographic information will be collected interview using the Patient Information Form. Approximately 30 minutes before surgery, patients' systolic and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded. Pain severity will also be assessed using the VAS, and anxiety levels will be assessed using the VAS-A and Spielberger Trait Anxiety Scale. Intraoperative Period: All patients will be placed in the supine position on the operating room table. Patients in the intervention group will continue to use the stress ball for 15 minutes during the surgery, as per randomization. All patients will undergo a repeat 15-minute postoperative assessment of vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation), pain with a VAS, and anxiety levels with a VAS-A. After the patients are taken to the clinic after the surgery, the same physiological measurements will repeated 10 mnt later | Behavioural | intervention group |
Primary outcome
Spielberger State-Trait Anxiety Inventory
Time frame: 5 months
Developed by Spielberger and colleagues in 1970, this scale consists of two 20-item sections: the State Anxiety Inventory (STAI-I) and the Trait Anxiety Inventory (STAI-II). When assessing state anxiety, participants are asked to select one of the following options: "not at all," "a little," "a lot," or "completely." On the trait anxiety scale, responses are given as "almost never," "sometimes," "most of the time," or "most of the time." The scale's score ranges from 20 to 80, with higher scores indicating higher anxiety levels. In this study, the STAI-II scale will be administered preoperatively to assess patients' general anxiety levels and to identify differences in trait anxiety between groups.
Visual Anxiety Scale (VAS-A)
Time frame: 5 months
The Visual Anxiety Scale (VAS-A) is a simple, single-question measurement tool developed to assess individuals' anxiety levels. This method, long used in psychological analyses, is now widely used to assess pain, quality of life, and mood. The scale features a 10-centimeter horizontal line labeled "No anxiety" and "Very high anxiety." Patients mark the point on this line corresponding to their perceived anxiety level, and the distance between these marks is measured in millimeters to score the point. A higher measurement indicates a higher anxiety level. Despite its short length, the VAS-A is a tool with proven validity and reliability.
Visual Pain Scale (VAS)
Time frame: 5 months
Visual Pain Scale (VAS): The Visual Pain Scale (VAS) is a 10-cm-long line that can be applied horizontally or vertically to measure the level of pain experienced by an individual. The left end of the line is designated as "no pain," and the right end as "unbearable pain." The location of the point marked by the patient numerically reflects the intensity of the pain; the higher the score, the greater the perceived pain.
Vital Signs Monitoring Form
Time frame: 5 months
Vital Signs Monitoring Form: The Vital Signs Monitoring Form was developed based on a literature review to monitor the physiological parameters of patients undergoing hernia surgery. The form regularly records heart rate, systolic and diastolic blood pressure, respiratory rate, and oxygen saturation before, during, and after surgery. This allows for objective assessment of patients' hemodynamic status. Additionally, a Visual Pain Scale is included to measure pain levels.
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 2 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress ball application in people with Hernia Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
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 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spielberger State-Trait Anxiety Inventory (time frame: 5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.