The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters
Primary Purpose
Cataract Surgery
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hand massage
Sponsored by
About this trial
This is an interventional supportive care trial for Cataract Surgery focused on measuring Anxiety, Fear of surgery, Pain, Hand massage, Cataract surgery
Eligibility Criteria
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
- <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.)
- 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.
Sites / Locations
- Erciyes university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hand massage group
Control group
Arm Description
The group that received hand massage for 10 minutes before cataract surgery
standard care group
Outcomes
Primary Outcome Measures
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.
Visual Analogue Scale (VAS)-Anxiety scores
According to the Visual Analogue Scale (VAS)-Anxiety, a high score indicates a high anxiety.
Secondary Outcome Measures
Visual Analogue Scale (VAS)-Pain scores
According to the Visual Analogue Scale (VAS)-Pain, a high score indicates a high pain.
Physiological parameters-blood pressure
systolic and diastolic blood pressure
Physiological parameters-respiratory rate
respiratory rate
Physiological parameters-pulse rate
pulse rate
Physiological parameters-oxygen saturation
oxygen saturation
Full Information
NCT ID
NCT05232513
First Posted
December 24, 2021
Last Updated
January 29, 2022
Sponsor
TC Erciyes University
1. Study Identification
Unique Protocol Identification Number
NCT05232513
Brief Title
The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters
Official Title
The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 24, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery
Keywords
Anxiety, Fear of surgery, Pain, Hand massage, Cataract surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Hand massage
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand massage group
Arm Type
Experimental
Arm Description
The group that received hand massage for 10 minutes before cataract surgery
Arm Title
Control group
Arm Type
No Intervention
Arm Description
standard care group
Intervention Type
Other
Intervention Name(s)
Hand massage
Intervention Description
Hand massage is an initiative that improves the communication between the massager and the individual, reduces anxiety, and provides comfort and relaxation.
Primary Outcome Measure Information:
Title
Surgical Fear Questionnaire (SFQ) scores
Description
SFQ is scored between 0-10, and an increase in the score from the scale indicates that the patients' fear of surgery increases.
Time Frame
before and immediately after the hand massage
Title
Visual Analogue Scale (VAS)-Anxiety scores
Description
According to the Visual Analogue Scale (VAS)-Anxiety, a high score indicates a high anxiety.
Time Frame
before and immediately after the hand massage, and postop 30.th minutes
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)-Pain scores
Description
According to the Visual Analogue Scale (VAS)-Pain, a high score indicates a high pain.
Time Frame
postop 30.th minutes
Title
Physiological parameters-blood pressure
Description
systolic and diastolic blood pressure
Time Frame
before and immediately after the hand massage, and postop 30.th minutes
Title
Physiological parameters-respiratory rate
Description
respiratory rate
Time Frame
before and immediately after the hand massage, and postop 30.th minutes
Title
Physiological parameters-pulse rate
Description
pulse rate
Time Frame
before and immediately after the hand massage, and postop 30.th minutes
Title
Physiological parameters-oxygen saturation
Description
oxygen saturation
Time Frame
before and immediately after the hand massage, and postop 30.th minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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,
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.
Exclusion Criteria:
<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.)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yağmur Sezer Efe, Assist. Prof.
Organizational Affiliation
ErciyesUniversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes university
City
Kayseri
Country
Turkey
12. IPD Sharing Statement
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The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters
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