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Anxiety LevelNCT05744141

The Effect Of Relaxation Exercises Before Cataract Surgery on Elderly İndividuals

A study testing Relaxation Exercises in people with Anxiety Level, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety Level
What is being tested?
Relaxation Exercises
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteTurkey (Türkiye)
Study dates
8 Nov 2022to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Beyoğlu Eye Training and Research Hospital

    Istanbul, Beyoğlu

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Relaxation Exercises Before Cataract Surgery On The Anxiety Level Of Elderly İndividuals

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

Read the 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.

Conditions
Anxiety Level
Being tested
Relaxation Exercises
Keywords
Nursing, Anxiety, Cataract, Relaxation Exercises
Medical subject headings
Anxiety Disorders, Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Relaxation ExercisesProcedure or surgery

    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).

Study groups in NCT05744141
Study groupRoleWhat they receive
Intervention GroupExperimentalElderly individuals undergoing relaxation exercises before cataract surgery
Receives: Procedure: Relaxation Exercises
Control GroupNo interventionStandard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: before the relaxation exercise

  3. 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

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

  4. Change in Blood Pressure

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

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

  5. Change in Pulse Rate

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

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

  6. Change in Respiratory Rate

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

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

  7. 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.

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

  8. Change in Body Temperature

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

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

Secondary outcomes (1)

  1. Change in Satisfaction as Measured by Visual Analog Scale

    Measured using the Visual Analogue Scale for Satisfaction, on a scale of 0 to 10, in which a higher score means an increased level of satisfaction

    Measured: before and immediately after the relaxation exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start8 Nov 2022
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05744141
Sponsor's protocol ID
E-48670771-514.99
Status last verified
Feb 2023
First submitted
10 Jan 2023
Last updated
24 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. doi: 10.1177/003591576906201005. No abstract available.

    PubMed 4899510

  • Akoğlu, C., & Çelik, G. K. (2020). Katarakt ameliyatı esnasında ağrı ve anksiyete: birinci göz ve ikinci göz cerrahisi arasında karşılaştırma. http://79.123.186.155/handle/20.500.11787/826

  • Aydemir, Ö. ve Köroğlu, E. (2000). Psikiyatri'de Kullanılan Ölçekler. Ankara: Hekimler Yayın Birliği; 153-163.

  • Babacan-Yildiz G, Ur-Ozcelik E, Kolukisa M, Isik AT, Gursoy E, Kocaman G, Celebi A. [Validity and Reliability Studies of Modified Mini Mental State Examination (MMSE-E) For Turkish Illiterate Patients With Diagnosis of Alzheimer Disease]. Turk Psikiyatri Derg. 2016 Spring;27(1):41-6. Turkish.

    PubMed 27369684

  • Beaver, H. A. (2019). Cataracts and cataract surgery. Geriatric Ophthalmology: A Competency-Based Approach: Second Edition, 16-26. https://doi.org/10.1007/978-3-030-04019-2_3

  • Chen M, Hill GM, Patrianakos TD, Ku ES, Chen ML. Oral diazepam versus intravenous midazolam for conscious sedation during cataract surgery performed using topical anesthesia. J Cataract Refract Surg. 2015 Feb;41(2):415-21. doi: 10.1016/j.jcrs.2014.06.027.

    PubMed 25661136

  • Choi S, Park SG, Bellan L, Lee HH, Chung SK. Crossover clinical trial of pain relief in cataract surgery. Int Ophthalmol. 2018 Jun;38(3):1027-1033. doi: 10.1007/s10792-017-0554-y. Epub 2017 Jun 20.

    PubMed 28639089

  • Cline ME, Herman J, Shaw ER, Morton RD. Standardization of the visual analogue scale. Nurs Res. 1992 Nov-Dec;41(6):378-80. No abstract available.

    PubMed 1437591

  • Cavdar AU, Yilmaz E, Baydur H. The Effect of Hand Massage Before Cataract Surgery on Patient Anxiety and Comfort: A Randomized Controlled Study. J Perianesth Nurs. 2020 Feb;35(1):54-59. doi: 10.1016/j.jopan.2019.06.012. Epub 2019 Sep 21.

    PubMed 31551136

  • Dahshan D, Kuzbel J, Verma V. A role for music in cataract surgery: a systematic review. Int Ophthalmol. 2021 Dec;41(12):4209-4215. doi: 10.1007/s10792-021-01986-9. Epub 2021 Jul 26.

    PubMed 34312781

  • Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9.

    PubMed 23860442

  • Farmahini Farahani M, Noruzi Zamenjani M, Nasiri M, Shamsikhani S, Purfarzad Z, Harorani M. Effects of Extremity Massage on Preoperative Anxiety: A Three-Arm Randomized Controlled Clinical Trial on Phacoemulsification Candidates. J Perianesth Nurs. 2020 Jun;35(3):277-282. doi: 10.1016/j.jopan.2019.10.010. Epub 2020 Feb 10.

    PubMed 32057627

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

  • Gadegone, A., Daigavane, S., & Walavalkar, R. (2021). Effect of Music on Blood Pressure and Heart Rate in Patients Undergoing Cataract Extraction Surgery. Original Research Article J Evolution Med Dent Sci, 10. https://doi.org/10.14260/jemds/2021/309

  • Giannaccare G, Bernabei F, Pellegrini M, Guaraldi F, Turchi F, Torrazza C, Senni C, Scotto R, Sindaco D, Di Cello L, Versura P, Scorcia V, Traverso CE, Vagge A. Bilateral morphometric analysis of corneal sub-basal nerve plexus in patients undergoing unilateral cataract surgery: a preliminary in vivo confocal microscopy study. Br J Ophthalmol. 2021 Feb;105(2):174-179. doi: 10.1136/bjophthalmol-2019-315449. Epub 2020 Apr 3.

    PubMed 32245849

Questions about this trial

What is this clinical trial studying?

A study testing Relaxation Exercises in people with Anxiety Level, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in STAI-S's Inventory (time frame: before and immediately after the relaxation exercise and before surgery (in the operating room waiting room)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05744141, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.

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