The Effect Of Relaxation Exercises Before Cataract Surgery on Elderly İndividuals

NCT05744141 | Unknown

• 1 other identifier: E-48670771-514.99
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine the effect of relaxation exercises applied before cataract surgery on the anxiety level of elderly individuals.

Conditions

Anxiety Level

Keywords

Nursing; Anxiety; Cataract; Relaxation Exercises

Outcome Measures

Primary Outcomes (8)

• Change in STAI-S's Inventory

  State anxiety (STAI-S) refers to a temporary emotional state related to a specific situation. The STAI -S consists of 20 items. The total score obtained from the scale is between 20-80 and an increase in the score indicates an increase in the level of anxiety. The validity and reliability of the Turkish versions of these instruments have been validated.

  before and immediately after the relaxation exercise and before surgery (in the operating room waiting room)

• STAI-T's Inventory

  Trait anxiety (STAI-T) represents anxiety as a stable personality character. The STAI -T consists of 20 items. The total score obtained from the scale is between 20-80 and an increase in the score indicates an increase in the level of anxiety. The validity and reliability of the Turkish versions of these instruments have been validated.

  before the relaxation exercise

• Change in Anxiety as Measured by Visual Analog Scale (VAS-A)

  Measured using the Visual Analogue Scale for Anxiety (VAS-A), on a scale of 0 to 10, in which a higher score means an increased level of anxiety

  before and immediately after the relaxation exercise, in the operating room waiting room and immediately before surgery.

• Change in Blood Pressure

  A calibrated digital sphygmomanometer will be used to measure blood pressure. Results will be reported in mmHg.

  before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery

• Change in Pulse Rate

  Calibrated digital finger type pulse oximeter will be used for pulse measurement. The results presented as beat per minute.

  before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery

• Change in Respiratory Rate

  Respiratory rate per minute. Higher scores mean a worse result.

  before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery

• Change in Peripheral Oxygen Saturation (SpO2)

  Calibrated digital finger type pulse oximeter will be used for Peripheral Oxygen Saturation (SpO2). Approaching 100% is considered positive. Higher scores mean a better result.

  before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery

• Change in Body Temperature

  A calibrated non-contact infrared thermometer will be used to measure body temperature. Results will be reported in Celcius.

  before and immediately after the relaxation exercise, in the operating room waiting room (before surgery )

Secondary Outcomes (1)

• Change in Satisfaction as Measured by Visual Analog Scale

  before and immediately after the relaxation exercise

Study Arms (2)

Intervention Group

EXPERIMENTAL

Elderly individuals undergoing relaxation exercises before cataract surgery

Procedure: Relaxation Exercises

Control Group

NO INTERVENTION

Standard care

Interventions

Relaxation Exercises PROCEDURE

Relaxation exercises consist of voluntary, rhythmic and regular stretching and relaxation of large and small muscle groups until the whole body relaxes. For this exercise application, the "Relaxation Exercises CD" prepared by the Turkish Psychological Association will be used. The CD consists of 30 minutes and relaxation exercises are explained with the sound of a stream accompanied by verbal instructions. This exercise includes rhythmic breathing, muscle relaxation exercises and music (stream sound).

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older,
• At least be able to read and write,
• No problems in terms of hearing, communication (verbal / non-verbal),
• Can communicate in Turkish,
• Mini Mental State Examination Test score of 25 points and above,
• First time cataract surgery under planned topical/local anesthesia.

You may not qualify if:

• Lacking cognitive competence,
• Additional eye problems other than cataracts,
• According to the STAI, with additional anxiety problems other than surgery,
• Known psychiatric problems,
• Developing complications during surgery,
• Elderly individuals who have to undergo different anesthesia will not be included in the study.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Beyoğlu Eye Training and Research Hospital

Istanbul, Beyoğlu, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Anxiety Disorders; Cataract

Condition Hierarchy (Ancestors)

Mental Disorders; Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 24, 2023
• Study Start: November 8, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

TU (1)