Effects of WN and WF During Gastroscopy (WF/WN_GCPY)

March 22, 2024 updated by: Hasan Genç, Suleyman Demirel University

The Effects of Glass Waterfall and White Noise on Pain, Anxiety and Physiological Parameters During Gastroscopy

Background: Gastroscopy is an endoscopic procedure that allows examination of the upper gastrointestinal system, including the esophagus, stomach and duodenum. The procedure is a difficult and stressful diagnosis and treatment method for the patient. Problems such as stress, fear and pain experienced during endoscopy cause anxiety.

Purpose: To examine effects of glass waterfall and white noise on pain, anxiety and physiological parameters during gastroscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for gastroscopy. The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 1.16, 95% power and 0.05% margin of error for this study, that a total of 156 individuals for the three groups and at 52 individuals for each group. Before gastroscopy procedure, the patients included in the study will be randomly divided into three groups: 52 glass waterfall group, 52 white noise group and 52 control group.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Gastroscopy is an endoscopic procedure that allows examination of the upper gastrointestinal system, including the esophagus, stomach and duodenum. The procedure is a difficult and stressful diagnosis and treatment method for the patient. Problems such as stress, fear and pain experienced during endoscopy cause anxiety.

Purpose: To examine effects of glass waterfall and white noise on pain, anxiety and physiological parameters during gastroscopy Method: The population of the study consists of all patients who will apply to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and will be scheduled for gastroscopy. The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis will be performed and it is found the effect size of 1.16, 95% power and 0.05% margin of error for this study, that a total of 156 individuals for the three groups and at 52 individuals for each group. Before gastroscopy procedure, the patients included in the study will be randomly divided into three groups: 52 glass waterfall group, 52 white noise group and 52 control group.

Data will be collected in the endoscopy unit on weekdays when the procedure is performed. All participants in the study will first fill out a patient identification form containing patient demographic information.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 aged and over
  • Written and verbal consent to participate in the study,
  • Being conscious (person, place and time orientation),
  • Undergoing gastroscopy for the first time

Exclusion Criteria:

  • Having vision, hearing and communication problems
  • Having any psychiatric and cognitive/mental mental health problems, disease (dementia, etc.),
  • Diagnosed with visual, auditory and / or balance disorders,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glass Waterfall
Except for the preparation the gastroscopy procedure takes approximately 20 minutes, patients will be asked to focus on portative glass waterfall during the procedure.
Device: Glass Waterfall group
Except for the preparation the gastroscopy procedure takes approximately 20 minutes, patients will be asked to focus on portative glass waterfall during the procedure.
Experimental: White Noise
Except for the preparation of the patient for the procedure, since the gastroscopy procedure takes approximately 20 minutes, 20-minute white noise be listened using phone
Device: white noise group
Except for the preparation of the patient for the procedure, since the gastroscopy procedure takes approximately 20 minutes, 20-minute white noise be listened using phone
No Intervention: control group
Patients of the control group, will not receive any intervention except for applied routine hospital gastroscopy procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Information Form
Time Frame: the fundamental characteristics of the patients will be filled in 15 minutes before the gastroscopy procedure
This form, which will be created by the researcher; Patients' age, gender, education level, marital status, employment status, income level, chronic disease status, previous surgery, complaints about coming to the hospital, whether they would prefer the current method if they need to have gastroscopy again, It consists of a total of 10 questions.
the fundamental characteristics of the patients will be filled in 15 minutes before the gastroscopy procedure
Visual Analogue Scale (VAS)
Time Frame: Change from Baseline Visual Analogue Scale in 50 minutes

This scale developed by Price (1983) will be used in the research to determine the level of tolerance, comfort and satisfaction. It is a scale in which the distance between the two ends with a minimum value of 0 on one end and a maximum value of 10 on the other end is measured with a 10 cm ruler. In this context; The patient is explained that there are two endpoints and that he is free to mark any place between them that fits the severity of his pain.

The distance between the beginning of "no comfort, tolerance and satisfaction" and this point marked by the patient is measured and recorded in centimeters. It has been shown that the VAS is a valid tool for the measurement of psychological and health variables such as pain and satisfaction, which is widely used in clinical studies
Change from Baseline Visual Analogue Scale in 50 minutes
State and Trait Anxiety Scale (STAI)
Time Frame: Change from Baseline The State and Trait Anxiety Scale in 50 minutes
It is a self-assessment questionnaire developed by Spielberger et al. and consists of short assessments. The STAI includes 40 four-point Likert-type items ranging from "None" to "Completely". The validity and reliability of the STAI in Turkey were established by Öner and Le Compte. The STAI includes two separate scales, the State Anxiety Score (SAS) and the Trait Anxiety Score (TAS). The SAS requires the person to describe how they feel at a certain moment and under certain conditions and to respond by taking into account their feelings about the situation they are in. Higher scores indicate increased anxiety level. In the Turkish validity and reliability study, Cronbach's alpha reliability coefficients were between 0.83 and 0.87 for the TAS and between 0.94 and 0.96 for the SAS.
Change from Baseline The State and Trait Anxiety Scale in 50 minutes
The Patient Observation Form
Time Frame: Change from Baseline The Patient Observation Form in 50 minutes
This form will be created by the researcher based on the literature review, the physiological parameters (pulse (min), respiratory rate (min), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and oxygen saturation values (%)) of the patients before and after the procedure will be recorded the form. Researcher will has a automatic blood pressure monitor and a probe device for recording the variables in the endoscopy unit. While the patients' physiological parameters will being taken, a fully automatic blood pressure monitor will be used to measure blood pressure and pulse. To measure the respiratory rate, the patient placed his hand on his chest and his chest movements will be counted and recorded for one minute. Oxygen saturation level will be measured from the index finger with a probe device. Data will be collected by recording all parameters measurement values on a single form. The form will similar to forms commonly used in nursing research.
Change from Baseline The Patient Observation Form in 50 minutes
Pulse rate before and after gatroscopy procedure
Time Frame: Change from Baseline Pulse rate in 50 minutes
60 to 100 beats per minute is normal. It will be recorded 15 minutes before and after the gastroscopy procedure
Change from Baseline Pulse rate in 50 minutes
Respiratory rate before and after gatroscopy procedure
Time Frame: Change from Baseline Respiratory rate in 50 minutes
12 to 18 breaths per minute is normal. It will be recorded 15 minutes before and after the gastroscopy procedure
Change from Baseline Respiratory rate in 50 minutes
Systolic and diastolic blood pressure before and after gatroscopy procedure
Time Frame: Change from Baseline Systolic and diastolic blood pressure in 50 minutes
90/60 mm Hg to 120/80 mm Hg is normal. It will be recorded 15 minutes before and after the gastroscopy procedure
Change from Baseline Systolic and diastolic blood pressure in 50 minutes
Oxygen saturation values before and after gatroscopy procedure
Time Frame: Change from Baseline Oxygen saturation values in 50 minutes
Normal oxygen saturation usually ranges from 95 to 100%. It will be recorded 15 minutes before and after the gastroscopy procedure
Change from Baseline Oxygen saturation values in 50 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suleyman Demirel University

Investigators

  • Principal Investigator: Hasan GENC, PhD, Dicle University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 3, 2024

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

June 8, 2024

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WN/WF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

all IPD that underlie results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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