Clinical trial NCT05744141: The Effect Of Relaxation Exercises Before Cataract Surgery on Elderly İndividuals
Official title: The Effect Of Relaxation Exercises Before Cataract Surgery On The Anxiety Level Of Elderly İndividuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Level
Keywords: Nursing
Anxiety
Cataract
Relaxation Exercises
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The study was planned as a randomized controlled study to determine the effect of relaxation exercises applied before cataract surgery on the anxiety level of elderly individuals. In this context, as a result of the study, it will be concluded about the effect of relaxation exercises applied before cataract surgery on the anxiety level of elderly individuals. It is also aimed to evaluate the effect of relaxation exercises on the preoperative and intraoperative vital signs of elderly individuals and their satisfaction level with the intervention.

Patients who meet the inclusion criteria will be informed about the purpose, content and method of the study during patient admission in the preoperative period, and the sample group (experimental and control) will be formed by obtaining written permission from those who voluntarily agree to participate in the study. The determination of the experimental and control groups will be provided by the random numbers generated by the https://www.randomizer.org/ website. In the sample group (experimental, control), a pilot study will be conducted to evaluate the applicability of the study plan before the implementation (10 experimental, 10 control). In addition, the researcher will explain the application of relaxation exercises within the scope of the research to the patients in the experimental group by accepting the intervention application in the preoperative period.

Formation of the Experimental Group and Interventions:

* First, patients who meet the sample selection criteria will be identified.
* Standardized Mini Mental Test will be administered to patients who are eligible for the study. Patients with a score of 25 and above will be informed about the purpose, content and method of the study by reading the voluntary information form, and those who voluntarily agree to participate in the study and accept the intervention will be included in the study by obtaining verbal and written consent. According to the order of inclusion in the study, the experimental group will be formed from the numbers generated by the https://www.randomizer.org/ website.
* Cataract surgery (phacoemulsification) is usually performed on a daily basis. In this period, firstly, the Information Form will be applied to the patients. Then, preoperative State-Trait Anxiety Inventory and Visual Comparison Scale will be used to determine anxiety levels and vital signs will be evaluated.
* The non-pharmacologic relaxation exercise method will be explained to the patient by the researcher.
* In order to ensure that the 30-minute relaxation exercises can be performed in a comfortable environment, the patient can relax sufficiently, and the patients can make independent decisions in anxiety assessments; care will be taken to ensure that the patient's relatives are not present in the room, the curtain / screen on the patient's bed is closed, there is no urgency for urinary and bowel evacuation, the CD volume is adjusted according to the patient's preference, and the room is quiet and calm. An eye patch will be used during this period to minimize environmental factors.
* Immediately after the intervention, the State Anxiety Inventory and Visual Comparison Scale will be used to measure the individual's anxiety, satisfaction level with the intervention and vital signs will be evaluated.
* When the individual arrives at the operating room, his/her anxiety level and vital signs will be assessed in the waiting room using the State Anxiety Inventory and Visual Comparison Scale. During the operation, vital signs will be monitored on the monitor at 5 minute intervals. The interpretation of vital signs during the operation will be based on the average value of the measurements.

Relaxation Exercises Practice:

* 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; "Relaxation Exercises CD" prepared by the Turkish Psychologists Association will be used.
* The CD consists of 3 parts. In the first part, the definition and purpose of 10 minutes of deep relaxation and the practices to be considered during the exercise are explained. The second part consists of 30 minutes and explains relaxation exercises with the sound of a stream accompanied by verbal instructions. The 3rd part consists of 30 minutes and includes only relaxation music without instructions.
* In this study, only the second part of the "Relaxation Exercises CD" will be used and it will be applied in the patient's room/bed by the researcher by using a portable VCD/DVD player, adjusting the volume according to the patient's preference, with the help of headphones, taking into account the institutional policy in the preoperative period.

The elderly individuals in the control group will be measured in the same time period as the experimental group without any intervention.

Eligibility criteria: Inclusion Criteria:

* 65 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in STAI-S's Inventory
timeFrame: before and immediately after the relaxation exercise and before surgery (in the operating room waiting room)
measure: STAI-T's Inventory
timeFrame: before the relaxation exercise
measure: Change in Anxiety as Measured by Visual Analog Scale (VAS-A)
timeFrame: before and immediately after the relaxation exercise, in the operating room waiting room and immediately before surgery.
measure: Change in Blood Pressure
timeFrame: before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
measure: Change in Pulse Rate
timeFrame: before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
measure: Change in Respiratory Rate
timeFrame: before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
measure: Change in Peripheral Oxygen Saturation (SpO2)
timeFrame: before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
measure: Change in Body Temperature
timeFrame: before and immediately after the relaxation exercise, in the operating room waiting room (before surgery )
Secondary outcomes:
measure: Change in Satisfaction as Measured by Visual Analog Scale
timeFrame: before and immediately after the relaxation exercise
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beyoğlu Eye Training and Research Hospital
state: Beyoğlu
Study officials:
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