CholecystitisNCT06345768
The Effect of the Stress Ball Applied Before Colocystectomy Surgery on Patients; Surgical Fear, Anxiety and Comfort.
A study testing Stress Ball in people with Cholecystitis and Stress, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery. Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholecystitis, Stress, Fear
- What is being tested?
- Stress Ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Able to speak and understand Turkish
- Being literate
- Patients who underwent elective laparoscopic cholecystectomy
- Volunteering to participate in the study
Who cannot join
- Use of any analgesic or anxiolytic preoperatively
- Any physical obstacle to using a stress ball (patients with partial paralysis or weak hand muscles)
- History of psychiatric disorders or ongoing psychiatric treatment.
- Emergency surgery
- Open cholecystectomy
- Hearing or perception problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Üniversitesi Klinik Araştırma Etik Kurulu
Samsun, Merkez
About this study
Official title: Effect of Stress Ball Applied Before Cholecystectomy Surgery on Surgical Fear, Anxiety and Comfort of Patients: A Randomized Controlled Trial
Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.
Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.
In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort.
Read the detailed description
This study was planned to examine the effect of a stress ball applied to patients before laparoscopic cholecystectomy on preoperative anxiety, surgical fear and comfort. Patients were given a stress ball before the procedure, and the other group received routine care.
- Conditions
- Cholecystitis, Stress, Fear, Comfort
- Being tested
- Stress Ball
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress BallOther
The researcher obtained 6 cm-diameter, moderate hardness, compressible balls made of silicone material in similar colors, mainly blue and green tones, some of which combined both colors featuring an Earth motif, before the study. After patients in the intervention group applied the scale tools in the pretest, the intervention stage began. Patients were given stress balls. When patients were given information about the stress ball application, they were called squeeze balls with the aim of not inferring that the process was stressful. The participants were given the right to choose the stress ball (color and pattern preference). Patients were taught to count from one to three and to squeeze and relax the ball and were told to continue in this way until the end of the intervention. Additionally, they were requested to pay attention to the squeeze ball and squeeze with focus. The participants were asked to repeat this process for a total of 30 minutes, and the researcher remotely observed
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The researcher obtained 6 cm-diameter, moderate hardness, compressible balls made of silicone material in similar colors, mainly blue and green tones, some of which combined both colors featuring an Earth motif, before the study. Receives: Other: Stress Ball |
| Control group | No intervention | Patients included in the control group had no intervention performed after completing the scale tools on the pretest, and 30 minutes later, the Surgical Fear Questionnaire, VAS-A and General Comfort Questionnaire were administered (posttest). Patients in the control group were not given stress balls for the pretest or posttest. No intervention was applied to patients in the control group. The scales were completed by researchers via face-to-face interviews in the preoperative waiting unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of surgery
The scale consists of 8 items and is an 11-point Likert type, with each item scored between 0 (I am not afraid at all) and 10 (I am very afraid). bottom of scale The lowest score that can be obtained from the dimensions is 0, the highest score is 40, the lowest score that can be obtained from the total scale is 0 and the highest score is 80.
Measured: 30 minutes before surgery
Fear of surgery
The scale consists of 8 items and is an 11-point Likert type, with each item scored
Measured: Just before surgery
Comfort
The scale contains a total of 48 items in four/six point Likert type; Four-point Likert type was preferred due to its ease of use. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48.
Measured: 30 minutes before surgery
Comfort
The scale contains a total of 48 items in four/six point Likert type; Four-point Likert type was preferred due to its ease of use. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48.
Measured: Just before surgery
Stress
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: 30 minutes before surgery
Stress
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: Just before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start27 Mar 2024
- Primary completion30 Oct 2024
- Study completion30 Nov 2024
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 CholecystitisStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansu Yeniğün, Akdeniz University
- Investigators
- Hatice Merve Alptekin, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345768
- Sponsor's protocol ID
- Scy123456789
- Status last verified
- Nov 2025
- First submitted
- 23 Mar 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alptekin HM, Ulubay S, Yenigun Akbulut SC. Effect of stress ball use before cholecystectomy surgery on surgical fear, anxiety and comfort of patients: a randomized controlled trial. BMC Nurs. 2025 Nov 13;24(1):1395. doi: 10.1186/s12912-025-04057-x.
PubMed 41233781
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stress Ball Applied Before Cholecystectomy Surgery on Surgical Fear, Anxiety and Comfort of Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06345768
- Acronym / sponsor ID
- Scy123456789
- Conditions
- Cholecystitis, Stress, Fear, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 3 Apr 2024 (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.
Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.
Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.
In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort.
Detailed description
This study was planned to examine the effect of a stress ball applied to patients before laparoscopic cholecystectomy on preoperative anxiety, surgical fear and comfort. Patients were given a stress ball before the procedure, and the other group received routine care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Stress BallThe researcher obtained 6 cm-diameter, moderate hardness, compressible balls made of silicone material in similar colors, mainly blue and green tones, some of which combined both colors featuring an Earth motif, before the study. |
| Control group | No intervention | –Patients included in the control group had no intervention performed after completing the scale tools on the pretest, and 30 minutes later, the Surgical Fear Questionnaire, VAS-A and General Comfort Questionnaire were administered (posttest). Patients in the control group were not given stress balls for the pretest or posttest. No intervention was applied to patients in the control group. The scales were completed by researchers via face-to-face interviews in the preoperative waiting unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Able to speak and understand Turkish
- Being literate
- Patients who underwent elective laparoscopic cholecystectomy
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- Use of any analgesic or anxiolytic preoperatively
- Any physical obstacle to using a stress ball (patients with partial paralysis or weak hand muscles)
- History of psychiatric disorders or ongoing psychiatric treatment.
- Emergency surgery
- Open cholecystectomy
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 BallThe researcher obtained 6 cm-diameter, moderate hardness, compressible balls made of silicone material in similar colors, mainly blue and green tones, some of which combined both colors featuring an Earth motif, before the study. After patients in the intervention group applied the scale tools in the pretest, the intervention stage began. Patients were given stress balls. When patients were given information about the stress ball application, they were called squeeze balls with the aim of not inferring that the process was stressful. The participants were given the right to choose the stress ball (color and pattern preference). Patients were taught to count from one to three and to squeeze and relax the ball and were told to continue in this way until the end of the intervention. Additionally, they were requested to pay attention to the squeeze ball and squeeze with focus. The participants were asked to repeat this process for a total of 30 minutes, and the researcher remotely observed | Other | Intervention |
Primary outcome
Fear of surgery
Time frame: 30 minutes before surgery
The scale consists of 8 items and is an 11-point Likert type, with each item scored between 0 (I am not afraid at all) and 10 (I am very afraid). bottom of scale The lowest score that can be obtained from the dimensions is 0, the highest score is 40, the lowest score that can be obtained from the total scale is 0 and the highest score is 80.
Fear of surgery
Time frame: Just before surgery
The scale consists of 8 items and is an 11-point Likert type, with each item scored
Comfort
Time frame: 30 minutes before surgery
The scale contains a total of 48 items in four/six point Likert type; Four-point Likert type was preferred due to its ease of use. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48.
Comfort
Time frame: Just before surgery
The scale contains a total of 48 items in four/six point Likert type; Four-point Likert type was preferred due to its ease of use. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48.
Stress
Time frame: 30 minutes before 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".
Stress
Time frame: Just before 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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Derived from this study: PubMed 41233781Alptekin HM, Ulubay S, Yenigun Akbulut SC. Effect of stress ball use before cholecystectomy surgery on surgical fear, anxiety and comfort of patients: a randomized controlled trial. BMC Nurs. 2025 Nov 13;24(1):1395. doi: 10.1186/s12912-025-04057-x.
- 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.
Hatice Merve Alptekin principal investigator
Kocaeli University
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 in people with Cholecystitis and Stress, run by Akdeniz 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 6 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: finished, as of the sponsor's last update on 3 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fear of surgery (time frame: 30 minutes before surgery). 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 NCT06345768, 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 3 Dec 2025.