CataractNCT05847114
Evaluation of the Effectiveness of Stress Ball Practice During Cataract Surgery
A study testing Stres ball in people with Cataract and Anxiety, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Cataract surgery is one of the most commonly performed and reliable surgeries among eye diseases. While cataract surgeries were performed under general or local anesthesia in previous years, they are now performed topically. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Stres ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Sep 2022to 15 Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older,
- Absence of hearing and perception problems,
- Having no physical problems to squeeze a stress ball,
- First time cataract surgery.
Who cannot join
- Using any analgesic or anxiolytic before surgery,
- Conversion of topical anesthesia to general anesthesia during surgery,
- Having a psychiatric disorder
- Uncontrolled hypertension in the patient
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University
Izmir, Ege Üniversitesi Hemşirelik Fakültesi Bornova/İZMİR, 35100
About this study
Official title: Investigation of the Effects of Stress Ball Practice on Patients Anxiety, Pain and Vital Signs During Cataract Surgery
Cataract surgery is one of the most commonly performed and reliable surgeries among eye diseases. While cataract surgeries were performed under general or local anesthesia in previous years, they are now performed topically. Despite providing conscious sedation with agents such as benzodiazepines and opioids before and during surgery, patients experience pain, anxiety, and discomfort during the surgical procedure.
One of the non-pharmacological methods used to relieve acute pain during surgical intervention is stress ball. It is also used to reduce pain and anxiety and increase patient comfort. The stress ball suppresses most of the nerves and muscles directly connected to the brain around the wrist and hand, stimulating nerve and muscle activity. This mechanism reduces the release of stress hormones, regulates blood pressure by providing relaxation and relief, and helps reduce anxiety and acute stress.
When literature is examined, it is seen that stress ball application is effective on patients' pain, anxiety, and vital signs; however, no randomized controlled study has been found in which stress ball application was performed during cataract surgery. This study was planned to investigate the effect of stress ball application during cataract surgery on patients' anxiety, pain, and vital signs.
Read the detailed description
After obtaining the permission of the ethics committee and institution of the study, the researcher will go to the clinic and introduce herself to the patient who is hospitalized for cataract surgery and explain the purpose of the research. Informed consent will be obtained from patients willing to participate in the study. The data on the socio-demographic characteristics of the patients in the patient introduction form will be interviewed face-to-face with the patient, and the data on the clinical features of the patients will be recorded from the patient file. Data will begin to be collected from the first patient who will go to surgery. Systolic-diastolic blood pressure, heart rate, respiration, O2 saturation will be measured and recorded 5-10 minutes before the surgery. Pain levels with VAS, anxiety levels with VAS-A and Spielberg Trait Anxiety Scale will be checked. According to the randomization, the patient in the stress ball group will first be given the stress balls in both palms by the researcher, and they will be asked to count from one to five and squeeze them twice. The patient will be shown to use stress balls for 15 minutes during the surgery and will be applied. The patient will be explained to use the stress balls for 15 minutes during the surgery. When the 15 minutes are up, the patient will be informed by the researcher and the patient will be able to let go of the stress balls. No intervention will be performed on the patient in the control group. The first patient will go to the operating room. After the patient goes to the operating table and the preparation for the surgery is completed, the patients in the stress ball group will practice the stress balls for 15 minutes. No intervention will be performed on the patient in the control group. At the 15th minute of the operation, a scale will be applied to all patient groups to determine the level of pain with VAS and anxiety level with VAS-A, and systolic-diastolic blood pressure, heart rate, and O2 saturation will be measured and recorded. At the end of the cataract surgery, the patient will be transferred to the service. The patient who is transferred to the service will be rested. The patient's systolic-diastolic blood pressure, heart rate, O2 saturation will be measured and recorded after 10 minutes. In addition, a scale will be applied to the patient to determine the pain level with VAS and the level of anxiety with VAS-A. No intervention will be made to the control group patients, and the routine care protocol of the clinic will be applied.
- Being tested
- Stres ball
- Keywords
- cataract, stress ball, anxiety, pain, vital signs
- Medical subject headings
- Cataract, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stres ballOther
Stress ball compression for 15 minutes during surgery
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball Group | Experimental | VAS-A, VAS, Spielberg Trait Anxiety Inventory was applied. Vital signs were evaluated before, during and after surgery. Stress balls were given to the patients in addition to the standard care protocol. Stress balls were used for 15 minutes during the operation, by placing the patient in both hands, counting from one to five, and tightening and loosening twice. Receives: Other: Stres ball |
| 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.
Pain (Visual Analog Scale)
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.
The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain.
In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Measured: 15 minutes before surgery
Pain (Visual Analog Scale)
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.
The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain.
In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Measured: During surgery
Pain (Visual Analog Scale)
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.
The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain.
In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Measured: 10 minutes after surgery
Anxiety (Visual Analog Scale-Anxiety)
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety.
In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Measured: 15 minutes before surgery, during surgery and 10 minutes after surgery
State-Trait Anxiety Inventory (STAI-II)
STAI-II is a well-researched clinical tool for evaluating the tendency towards anxiety. A cut-off point of 39-40 typically indicates clinically significant symptoms of a state of anxiety.
Measured: 15 minutes before surgery
Vital signs
In the measurement of vital signs of individuals, devices that measure digital blood pressure and pulse, O2 saturation will be used by applying the necessary hygiene rules at patient transitions.The respiratory rate will also be checked.
Measured: 15 minutes before surgery, during surgery and 10 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start26 Sep 2022
- Primary completion24 Apr 2023
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Ege 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansu Yenigun, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847114
- Sponsor's protocol ID
- EGE-PhD-9319000443
- Status last verified
- Oct 2024
- First submitted
- 4 Apr 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Stress Ball Practice on Patients Anxiety, Pain and Vital Signs During Cataract Surgery
- ClinicalTrials.gov ID
- NCT05847114
- Acronym / sponsor ID
- EGE-PhD-9319000443
- Keywords
- cataract, stress ball, anxiety, pain, vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 6 May 2023 (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.
Cataract surgery is one of the most commonly performed and reliable surgeries among eye diseases. While cataract surgeries were performed under general or local anesthesia in previous years, they are now performed topically. Despite providing conscious sedation with agents such as benzodiazepines and opioids before and during surgery, patients experience pain, anxiety, and discomfort during the surgical procedure.
One of the non-pharmacological methods used to relieve acute pain during surgical intervention is stress ball. It is also used to reduce pain and anxiety and increase patient comfort. The stress ball suppresses most of the nerves and muscles directly connected to the brain around the wrist and hand, stimulating nerve and muscle activity. This mechanism reduces the release of stress hormones, regulates blood pressure by providing relaxation and relief, and helps reduce anxiety and acute stress.
When literature is examined, it is seen that stress ball application is effective on patients' pain, anxiety, and vital signs; however, no randomized controlled study has been found in which stress ball application was performed during cataract surgery. This study was planned to investigate the effect of stress ball application during cataract surgery on patients' anxiety, pain, and vital signs.
Detailed description
After obtaining the permission of the ethics committee and institution of the study, the researcher will go to the clinic and introduce herself to the patient who is hospitalized for cataract surgery and explain the purpose of the research. Informed consent will be obtained from patients willing to participate in the study. The data on the socio-demographic characteristics of the patients in the patient introduction form will be interviewed face-to-face with the patient, and the data on the clinical features of the patients will be recorded from the patient file. Data will begin to be collected from the first patient who will go to surgery. Systolic-diastolic blood pressure, heart rate, respiration, O2 saturation will be measured and recorded 5-10 minutes before the surgery. Pain levels with VAS, anxiety levels with VAS-A and Spielberg Trait Anxiety Scale will be checked. According to the randomization, the patient in the stress ball group will first be given the stress balls in both palms by the researcher, and they will be asked to count from one to five and squeeze them twice. The patient will be shown to use stress balls for 15 minutes during the surgery and will be applied. The patient will be explained to use the stress balls for 15 minutes during the surgery. When the 15 minutes are up, the patient will be informed by the researcher and the patient will be able to let go of the stress balls. No intervention will be performed on the patient in the control group. The first patient will go to the operating room. After the patient goes to the operating table and the preparation for the surgery is completed, the patients in the stress ball group will practice the stress balls for 15 minutes. No intervention will be performed on the patient in the control group. At the 15th minute of the operation, a scale will be applied to all patient groups to determine the level of pain with VAS and anxiety level with VAS-A, and systolic-diastolic blood pressure, heart rate, and O2 saturation will be measured and recorded. At the end of the cataract surgery, the patient will be transferred to the service. The patient who is transferred to the service will be rested. The patient's systolic-diastolic blood pressure, heart rate, O2 saturation will be measured and recorded after 10 minutes. In addition, a scale will be applied to the patient to determine the pain level with VAS and the level of anxiety with VAS-A. No intervention will be made to the control group patients, and the routine care protocol of the clinic will be applied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Ball Group | Experimental | Other: Stres ballVAS-A, VAS, Spielberg Trait Anxiety Inventory was applied. Vital signs were evaluated before, during and after surgery. Stress balls were given to the patients in addition to the standard care protocol. Stress balls were used for 15 minutes during the operation, by placing the patient in both hands, counting from one to five, and tightening and loosening twice. |
| 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older,
- Absence of hearing and perception problems,
- Having no physical problems to squeeze a stress ball,
- First time cataract surgery.
Key exclusion criteria (4 listed)
- Using any analgesic or anxiolytic before surgery,
- Conversion of topical anesthesia to general anesthesia during surgery,
- Having a psychiatric disorder
- Uncontrolled hypertension in the patient
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 |
|---|---|---|
| Stres ballStress ball compression for 15 minutes during surgery | Other | Stress Ball Group |
Primary outcome
Pain (Visual Analog Scale)
Time frame: 15 minutes before surgery
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Pain (Visual Analog Scale)
Time frame: During surgery
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Pain (Visual Analog Scale)
Time frame: 10 minutes after surgery
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Anxiety (Visual Analog Scale-Anxiety)
Time frame: 15 minutes before surgery, during surgery and 10 minutes after surgery
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
State-Trait Anxiety Inventory (STAI-II)
Time frame: 15 minutes before surgery
STAI-II is a well-researched clinical tool for evaluating the tendency towards anxiety. A cut-off point of 39-40 typically indicates clinically significant symptoms of a state of anxiety.
Vital signs
Time frame: 15 minutes before surgery, during surgery and 10 minutes after surgery
In the measurement of vital signs of individuals, devices that measure digital blood pressure and pulse, O2 saturation will be used by applying the necessary hygiene rules at patient transitions.The respiratory rate will also be checked.
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 10 Oct 2024.
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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 Stres ball in people with Cataract and Anxiety, run by Ege 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 4 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: finished, as of the sponsor's last update on 10 Oct 2024. 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?
Pain (Visual Analog Scale) (time frame: 15 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?
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 10 Oct 2024.