The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters

Cataract Surgery Clinical Trial

Official title:

The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05232513
• Other study ID #: 2020/500
• Status: Completed
• Phase: N/A
• Start date: December 24, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: January 2022
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Intervention

Other:
• Hand massage
Hand massage is an initiative that improves the communication between the massager and the individual, reduces anxiety, and provides comfort and relaxation.

Locations

Country	Name	City	State
Turkey	Erciyes university	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before and immediately after the hand massage
Primary	Visual Analogue Scale (VAS)-Anxiety scores	According to the Visual Analogue Scale (VAS)-Anxiety, a high score indicates a high anxiety.	before and immediately after the hand massage, and postop 30.th minutes
Secondary	Visual Analogue Scale (VAS)-Pain scores	According to the Visual Analogue Scale (VAS)-Pain, a high score indicates a high pain.	postop 30.th minutes
Secondary	Physiological parameters-blood pressure	systolic and diastolic blood pressure	before and immediately after the hand massage, and postop 30.th minutes
Secondary	Physiological parameters-respiratory rate	respiratory rate	before and immediately after the hand massage, and postop 30.th minutes
Secondary	Physiological parameters-pulse rate	pulse rate	before and immediately after the hand massage, and postop 30.th minutes
Secondary	Physiological parameters-oxygen saturation	oxygen saturation	before and immediately after the hand massage, and postop 30.th minutes