Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05232513
Study type Interventional
Source TC Erciyes University
Contact
Status Completed
Phase N/A
Start date December 24, 2020
Completion date May 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT02573610 - Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery Phase 3
Completed NCT02910362 - Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines N/A
Recruiting NCT01193504 - Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification Phase 4
Completed NCT01455233 - 2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery Phase 4
Completed NCT01199510 - Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery Phase 4
Completed NCT04146961 - The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
Completed NCT00585975 - Efficacy and Safety of Bromfenac Ophthalmic Solution Phase 2
Completed NCT00406913 - Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery N/A
Not yet recruiting NCT04131335 - Use of Prophylactic Lubricating Drops After Cataract Surgery N/A
Recruiting NCT05331690 - Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN) Phase 4
Withdrawn NCT04563559 - PREFERENTIAL Study Phase 2/Phase 3
Completed NCT04732351 - Evaluation of the Active Sentry System During Cataract Surgery With the Centurion Phacoemulsifier
Completed NCT02128113 - RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD Phase 2
Completed NCT03873454 - The Effects of Music on Perioperative Outcomes in Cataract Surgery N/A
Completed NCT04769856 - Impact of Non-fasting on Anxiety in Cataract Surgery N/A
Withdrawn NCT00604305 - Comperative Trial Between an Accommodative Iol and Monofocal Iol N/A
Completed NCT05925894 - Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma. N/A
Not yet recruiting NCT06136780 - Impact of Free Reading Glasses on Work and Visual Function Following Cataract Surgery in Honduras N/A
Completed NCT04633954 - Brimonidine for Subconjunctival Hemorrhage From Femtosecond Laser Assisted Cataract Surgery N/A
Completed NCT03644875 - Study of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber