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

NCT05232513 | Completed

• 1 other identifier: 2020/500
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Surgery

Keywords

Anxiety; Fear of surgery; Pain; Hand massage; Cataract surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Visual Analogue Scale (VAS)-Pain scores

  postop 30.th minutes

• Physiological parameters-blood pressure

  before and immediately after the hand massage, and postop 30.th minutes

• Physiological parameters-respiratory rate

  before and immediately after the hand massage, and postop 30.th minutes

• Physiological parameters-pulse rate

  before and immediately after the hand massage, and postop 30.th minutes

• Physiological parameters-oxygen saturation

  before and immediately after the hand massage, and postop 30.th minutes

Study Arms (2)

Hand massage group

EXPERIMENTAL

The group that received hand massage for 10 minutes before cataract surgery

Other: Hand massage

Control group

NO INTERVENTION

standard care group

Interventions

Hand massage OTHER

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

Hand massage group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes university

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yağmur Sezer Efe, Assist. Prof.

  ErciyesUniversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Yağmur Sezer Efe

Model Details: Hand massage

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: February 10, 2022
• Study Start: December 24, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-01

Locations

TU (1)