Cataract SurgeryNCT05232513
The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters
A study testing Hand massage in people with Cataract Surgery, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
ABSTRACT Objective: The research was conducted as a prospective randomized controlled experimental study to determine the effect of hand massage applied before cataract surgery on anxiety, surgical fear, pain and physiological parameters of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Hand massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2020to 31 May 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The 18-80 years old,
- Cataract surgery will be performed using local anesthesia,
- Collaborative and without communication problems (language problems, speech and hearing problems, etc.),
- Those who are conscious and able to answer questions and do not have any disorder/disease (dementia, Alzheimer's, psychological disorder, etc.)
- Open wounds on the skin or those who do not have an obstacle to massage (edema, abscess, skin infection with necrosis, thrombophlebitis, occlusive artery disease, loss of sensation in the hand, neuropathy, mass, fracture and ingrown nails, etc.),
- Does not have psychiatric diseases such as anxiety disorder, panic attack, depression,
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- Not receiving any psychiatric treatment such as antipsychotic/anxiolytic,
- Type 1 Diabetes patients who do not develop diabetic neuropathy (under 15 years of age, Type 2 Diabetes patients who have not completed 10 years of age),
- Patients who volunteered to participate in the study were included in the study.
Who cannot join
- <18 and >80 years old,
- who will undergo cataract surgery under general anesthesia,
- Having previously undergone cataract surgery,
- Having communication problems (language problems, speech and hearing problems, etc.),
- Having a history of LVH with advanced paralysis,
- Those who are not conscious, unable to answer questions, have any disorder/disease (dementia, Alzheimer's, psychological disorder, etc.)
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- Open wound on the skin or an obstacle to massage (edema, abscess, skin infection with necrosis, thrombophlebitis, occlusive artery disease, loss of sensation in the hand, mass, fracture and ingrown nails, neuropathy, etc.),
- Having psychiatric diseases such as anxiety disorder, panic attack, depression,
- Receiving psychiatric treatment such as antipsychotic/anxiolytic,
- Type 1 Diabetes patients who have developed diabetic neuropathy (over 15 years, Type 2 Diabetes patients who have completed 10 years),
- Patients who did not volunteer to participate in the study were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
ABSTRACT Objective: The research was conducted as a prospective randomized controlled experimental study to determine the effect of hand massage applied before cataract surgery on anxiety, surgical fear, pain and physiological parameters of patients.
Study design: The sample of the study consisted of 60 patients, 30 experimental and 30 control, who had cataract surgery and met the study criteria in Eye Operating Room of a tertiary hospital between 24 December 2020 and 31 May 2021. Ethics committee, institutional permission and participant consent were obtained in this study, and data were collected using the descriptive characteristics form, Physiological Parameters Observation Form (PPOF), VAS-Anxiety, Surgical Fear Scale (SFS), and VAS-Pain scale. In the study, individuals in the experimental group were given hand massage for 10 minutes before cataract surgery. Before and after hand massage, PPOF, VAS-Anxiety and SFS were measured and recorded. In addition, PPOF, VAS-Anxiety and VAS-Pain were measured and recorded again at the postoperative 30th minute. Pearson chi-square, Shapiro Wilk, Levene test, Two-Way Analysis of Variance in Repeated Measurements, Mann-Whitney U test were used in the analysis of the data.
Read the detailed description
This prospective randomized controlled experimental study is planned in order to determine the effect of hand massage applied before cataract surgery on patients' anxiety and fear of surgery, pain and physiological parameters.
The sample of the study consisted of 60 patients, 30 experimental and 30 control, who had cataract surgery and met the study criteria in Eye Operating Room of a tertiary hospital between 24 December 2020 and 31 May 2021. Ethics committee, institutional permission and participant consent were obtained in this study, and data were collected using the descriptive characteristics form, Physiological Parameters Observation Form (PPOF), VAS-Anxiety, Surgical Fear Scale (SFS), and VAS-Pain scale. In the study, individuals in the experimental group were given hand massage for 10 minutes before cataract surgery. Before and after hand massage, PPOF, VAS-Anxiety and SFS were measured and recorded. In addition, PPOF, VAS-Anxiety and VAS-Pain were measured and recorded again at the postoperative 30th minute. Pearson chi-square, Shapiro Wilk, Levene test, Two-Way Analysis of Variance in Repeated Measurements, Mann-Whitney U test were used in the analysis of the data.
The mean VAS-Anxiety score of the individuals in the experimental group after hand massage was 1.56±1.07, while the control group was 2.80±2.21 (p<0.05); While the VAS-Pain score of the experimental group was 1.00 (2.00), it was 2.00 (1.00) for the control group (p<0.05). It was determined that the mean total score of SFS of the individuals in the experimental group after hand massage was lower than the scores of the individuals in the control group (p<0.05). It was determined that the respiratory and systolic blood pressure values of the patients in the experimental group decreased after hand massage compared to the control group (p<0.05). It was determined that the pulse, SPO2, diastolic blood pressure (DBP) values of the patients in the experimental group after hand massage were not statistically significant compared to the control group (p>0.05). However, it was determined that the pulse and DBP values of the experimental group decreased after the hand massage compared to the values before the hand massage, while the SPO2 value increased.
According to these results; It was determined that hand massage applied before the surgery reduced the patients' anxiety and fear of surgery, positively affected their physiological parameters and reduced the pain levels of the patients. It may be recommended to apply hand massage before surgery in cataract and other surgeries to be performed under local anesthesia.
- Conditions
- Cataract Surgery
- Being tested
- Hand massage
- Keywords
- Anxiety, Fear of surgery, Pain, Hand massage, Cataract surgery
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand massageOther
Hand massage is an initiative that improves the communication between the massager and the individual, reduces anxiety, and provides comfort and relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Hand massage group | Experimental | The group that received hand massage for 10 minutes before cataract surgery Receives: Other: Hand massage |
| Control group | No intervention | standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Fear Questionnaire (SFQ) scores
SFQ is scored between 0-10, and an increase in the score from the scale indicates that the patients' fear of surgery increases.
Measured: before and immediately after the hand massage
Visual Analogue Scale (VAS)-Anxiety scores
According to the Visual Analogue Scale (VAS)-Anxiety, a high score indicates a high anxiety.
Measured: before and immediately after the hand massage, and postop 30.th minutes
Secondary outcomes (5)
Visual Analogue Scale (VAS)-Pain scores
According to the Visual Analogue Scale (VAS)-Pain, a high score indicates a high pain.
Measured: postop 30.th minutes
Physiological parameters-blood pressure
systolic and diastolic blood pressure
Measured: before and immediately after the hand massage, and postop 30.th minutes
Physiological parameters-respiratory rate
respiratory rate
Measured: before and immediately after the hand massage, and postop 30.th minutes
Physiological parameters-pulse rate
pulse rate
Measured: before and immediately after the hand massage, and postop 30.th minutes
Physiological parameters-oxygen saturation
oxygen saturation
Measured: before and immediately after the hand massage, and postop 30.th minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start24 Dec 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hand massage
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yağmur Sezer Efe, TC Erciyes University
- Investigators
- Yağmur Sezer Efe, Assist. Prof., Principal investigator, ErciyesUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232513
- Sponsor's protocol ID
- 2020/500
- Status last verified
- Jan 2022
- First submitted
- 24 Dec 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters
- ClinicalTrials.gov ID
- NCT05232513
- Acronym / sponsor ID
- 2020/500
- Conditions
- Cataract Surgery
- Keywords
- Anxiety, Fear of surgery, Pain, Hand massage, Cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 10 Feb 2022 (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.
ABSTRACT Objective: The research was conducted as a prospective randomized controlled experimental study to determine the effect of hand massage applied before cataract surgery on anxiety, surgical fear, pain and physiological parameters of patients.
Study design: The sample of the study consisted of 60 patients, 30 experimental and 30 control, who had cataract surgery and met the study criteria in Eye Operating Room of a tertiary hospital between 24 December 2020 and 31 May 2021. Ethics committee, institutional permission and participant consent were obtained in this study, and data were collected using the descriptive characteristics form, Physiological Parameters Observation Form (PPOF), VAS-Anxiety, Surgical Fear Scale (SFS), and VAS-Pain scale. In the study, individuals in the experimental group were given hand massage for 10 minutes before cataract surgery. Before and after hand massage, PPOF, VAS-Anxiety and SFS were measured and recorded. In addition, PPOF, VAS-Anxiety and VAS-Pain were measured and recorded again at the postoperative 30th minute. Pearson chi-square, Shapiro Wilk, Levene test, Two-Way Analysis of Variance in Repeated Measurements, Mann-Whitney U test were used in the analysis of the data.
Detailed description
This prospective randomized controlled experimental study is planned in order to determine the effect of hand massage applied before cataract surgery on patients' anxiety and fear of surgery, pain and physiological parameters.
The sample of the study consisted of 60 patients, 30 experimental and 30 control, who had cataract surgery and met the study criteria in Eye Operating Room of a tertiary hospital between 24 December 2020 and 31 May 2021. Ethics committee, institutional permission and participant consent were obtained in this study, and data were collected using the descriptive characteristics form, Physiological Parameters Observation Form (PPOF), VAS-Anxiety, Surgical Fear Scale (SFS), and VAS-Pain scale. In the study, individuals in the experimental group were given hand massage for 10 minutes before cataract surgery. Before and after hand massage, PPOF, VAS-Anxiety and SFS were measured and recorded. In addition, PPOF, VAS-Anxiety and VAS-Pain were measured and recorded again at the postoperative 30th minute. Pearson chi-square, Shapiro Wilk, Levene test, Two-Way Analysis of Variance in Repeated Measurements, Mann-Whitney U test were used in the analysis of the data.
The mean VAS-Anxiety score of the individuals in the experimental group after hand massage was 1.56±1.07, while the control group was 2.80±2.21 (p<0.05); While the VAS-Pain score of the experimental group was 1.00 (2.00), it was 2.00 (1.00) for the control group (p<0.05). It was determined that the mean total score of SFS of the individuals in the experimental group after hand massage was lower than the scores of the individuals in the control group (p<0.05). It was determined that the respiratory and systolic blood pressure values of the patients in the experimental group decreased after hand massage compared to the control group (p<0.05). It was determined that the pulse, SPO2, diastolic blood pressure (DBP) values of the patients in the experimental group after hand massage were not statistically significant compared to the control group (p>0.05). However, it was determined that the pulse and DBP values of the experimental group decreased after the hand massage compared to the values before the hand massage, while the SPO2 value increased.
According to these results; It was determined that hand massage applied before the surgery reduced the patients' anxiety and fear of surgery, positively affected their physiological parameters and reduced the pain levels of the patients. It may be recommended to apply hand massage before surgery in cataract and other surgeries to be performed under local anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Hand massage
| Arm | Type | Receives |
|---|---|---|
| Hand massage group | Experimental | Other: Hand massageThe group that received hand massage for 10 minutes before cataract surgery |
| Control group | No intervention | –standard care group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The 18-80 years old,
- Cataract surgery will be performed using local anesthesia,
- Collaborative and without communication problems (language problems, speech and hearing problems, etc.),
- Those who are conscious and able to answer questions and do not have any disorder/disease (dementia, Alzheimer's, psychological disorder, etc.)
- Open wounds on the skin or those who do not have an obstacle to massage (edema, abscess, skin infection with necrosis, thrombophlebitis, occlusive artery disease, loss of sensation in the hand, neuropathy, mass, fracture and ingrown nails, etc.),
Key exclusion criteria (11 listed)
- <18 and >80 years old,
- who will undergo cataract surgery under general anesthesia,
- Having previously undergone cataract surgery,
- Having communication problems (language problems, speech and hearing problems, etc.),
- Having a history of LVH with advanced paralysis,
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 |
|---|---|---|
| Hand massageHand massage is an initiative that improves the communication between the massager and the individual, reduces anxiety, and provides comfort and relaxation. | Other | Hand massage group |
Primary outcome
Surgical Fear Questionnaire (SFQ) scores
Time frame: before and immediately after the hand massage
SFQ is scored between 0-10, and an increase in the score from the scale indicates that the patients' fear of surgery increases.
Visual Analogue Scale (VAS)-Anxiety scores
Time frame: before and immediately after the hand massage, and postop 30.th minutes
According to the Visual Analogue Scale (VAS)-Anxiety, a high score indicates a high anxiety.
5 secondary outcomes
Visual Analogue Scale (VAS)-Pain scores
Time frame: postop 30.th minutes
Physiological parameters-blood pressure
Time frame: before and immediately after the hand massage, and postop 30.th minutes
Physiological parameters-respiratory rate
Time frame: before and immediately after the hand massage, and postop 30.th minutes
Physiological parameters-pulse rate
Time frame: before and immediately after the hand massage, and postop 30.th minutes
Physiological parameters-oxygen saturation
Time frame: before and immediately after the hand massage, and postop 30.th minutes
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 Feb 2022.
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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.
Yağmur Sezer Efe, Assist. Prof. principal investigator
ErciyesUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand massage in people with Cataract Surgery, run by TC Erciyes 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 9 inclusion and 11 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 Feb 2022. 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?
Surgical Fear Questionnaire (SFQ) scores (time frame: before and immediately after the hand massage). The study lists 2 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 Feb 2022.