Virtual Reality and Acupressure Applications; Effect on Pain, Anxiety, Vital Signs and Comfort

NCT ID: NCT05131620

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-25
• Study Completion Date: 2022-09-05

Brief Summary

Coronary angiography (CAG) is an invasive method for imaging the coronary arteries. The femoral artery is frequently used during CAG and patients feel pain and anxiety during removal of the catheters placed in the femoral region. These disorders also negatively affect the vital signs and comfort levels of patients.

Different methods are used in direct proportion to the development of technology for relieving anxiety and pain caused by invasive surgical procedures in patients. These methods include virtual reality (VR) applications. Innovative, up-to-date and original, virtual reality is the fusion of fiction and technology with reality and imagination. These programs; It is stated that in addition to reducing the patient's anxiety and pain, it makes them feel safe, increases their comfort, care satisfaction and positively affects their participation in care.

Acupressure is one of the most widely used non-pharmacological methods to reduce pain and anxiety, and one of the applications included in the Nursing Interventions Classification (NIC). Applications made with manipulations such as pressure and rubbing on certain points on the meridians where energy flow takes place in the body are called acupressure. It has been determined that acupressure applications in different areas reduce pain and anxiety and positively affect vital signs and patient comfort.

Although there are studies in the literature in which different non-pharmacological methods are applied to reduce pain and anxiety caused by catheter extraction after CAG, positively affect vital signs, and increase the level of comfort, no research has been found in which acupressure method and virtual reality methods developed with today's technology are applied together. In this study, it was planned to reduce the pain and anxiety of the patients, to observe the effects on vital signs, and to increase their comfort levels, with acupressure application and virtual reality methods, which have not been applied non-pharmacologically until now, in patients who underwent CAG.

Detailed Description

Before starting the research, permission was obtained from Çukurova University Medical Faculty Balcalı Hospital Cardiology Departmant, from Balcalı Hospital Chief Physician, and Çukurova Ethics Committee by the investigator . University Faculty of Medicine Non-Interventional Research Ethics Committee approval was received with the date and number of 02.10.2020/104 An application was made to the Scientific Research Projects Unit to support the project with all permissions. It has been approved as a Scientific Research Project.

Type of Research:

The study was planned as an experimental, randomized controlled trial with 3 groups.

Place and Date of the Research:

The study will be applied to patients who underwent coronary angiography in the Cardiology Department of Çukurova University Medical Faculty Balcalı Hospital October 2021. Cardiology department consists of 1 outpatient clinic, 1 intensive care unit, 1 service, 2 angiography laboratories and 46 patient beds.

Universe and Sample:

The universe of the research will be all patients who will undergo CAG in the Cardiology Department of a university hospital date 2021. A pilot study will be conducted for sampling purposes and 9 patients from each group will be recruited and completed with a total of 27 patients. Patients will be divided into 3 groups (2 experiments, 1 control) by computer randomization.

Data Collection Tools In the collection of data, Informed Voluntary Consent Form (IVCF), Personal Information Form (PIF), Visual Assessment Scale for pain (VAS-Visuel Analog Scale), State-Trait Anxiety Inventory for anxiety (STAI) was created by the researcher by scanning the literature. Perianesthesia Comfort Scale (PCS) will be used for comfort and vital signs will be measured.

Statistical analysis of the collected data will be done using a package program called SPSS (IBM SPSS Statistics 24).

Conditions

Pain; Anxiety; Vital Signs; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Venture in the Virtual Reality Group

Informed consent form will be signed by the patients who will be included in this group as a result of randomization, and a personal information form and STAI will be filled. After CAG, 10 minutes before the catheter extraction, the patients will be selected from videos such as park and nature walks, beach and seaside walks, underwater, museum tour, and virtual reality glasses will be put on and will be worn during the procedure. In the literature, VR glasses were put on 5-10 minutes before the procedure, continued throughout the procedure, and used for a total of 30-60 minutes. Catheter extraction takes approximately 15-20 minutes and it is planned to continue the virtual reality glasses viewing period for 30 minutes. VAS will be applied during the catheter extraction process, and VAS, SAI and PCS will be applied to all patients after catheter extraction. Vital signs of patients will be recorded before, during and after catheter extraction.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: PROCEDURE

It is planned that VR glasses are put on 5-10 minutes before the procedure and continued throughout the procedure, and the total monitoring time will continue for 30 minutes.

Venture in the Acupressure Group

Initiative in the Acupressure Group Informed consent form will be signed by the patients who will be included in this group as a result of randomization, and a personal information form and STAI will be filled. Acupressure will be applied 10 minutes before catheter extraction after CAG. Catheter extraction takes approximately 15-20 minutes. VAS will be applied during the catheter extraction process, and then VAS, SAI and PCS will be applied to all patients. Vital signs of patients will be recorded before, during and after catheter extraction.

Group Type: EXPERIMENTAL

Acupressure

Intervention Type: PROCEDURE

Acupressure will be applied 10 minutes before catheter extraction after CAG.

Control Group

Informed consent form will be signed by the patients who will be included in this group as a result of randomization, and a personal information form and STAI will be filled. Routine application will be made. VAS will be applied during the catheter extraction process, and then VAS, SAI and PCS will be applied to all patients. Vital signs of patients will be recorded before, during and after catheter extraction.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

It is planned that VR glasses are put on 5-10 minutes before the procedure and continued throughout the procedure, and the total monitoring time will continue for 30 minutes.

Intervention Type: PROCEDURE

Acupressure

Acupressure will be applied 10 minutes before catheter extraction after CAG.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Accepting the research
• Able to communicate in Turkish
• Patients whose clinical condition is stable
• between 18 and 88 years old
• No hearing problem
• CAG applied for the first time
• Undergoing a femoral intervention by placing a catheter in their femoral regions
• Those who have no previous psychiatric or mental illness

Exclusion Criteria

• Refusal to participate in the research
• Complication developed during the operation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Esma Gökçe

Principal Investigator (MSc)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cukurova University

Sarıçam, Adana, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

0000-0001-9581-6958

Identifier Type: -

Identifier Source: org_study_id