Clinical trial NCT05131620: Virtual Reality and Acupressure Applications; Effect on Pain, Anxiety, Vital Signs and Comfort
Official title: Virtual Reality and Acupressure Applications in the Catheter Extraction Process in Patients Undergoing Coronary Angiography; Effect on Pain, Anxiety, Vital Signs and Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Vital Signs
Virtual Reality
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 Group randomized
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Nonpharmacological method effects (pain)
timeFrame: [Time Frame: Primary VAS pain measurement will be taken at approximately 20th minutes, during the ongoing catheter withdrawal phase.]
measure: Nonpharmacological method effects (Anxiety)
timeFrame: [Time Frame: Primary STAI measurement will be performed before all groups are processed and catheter withdrawal begins. STAI measurement will be at take 0th minute.]
measure: Nonpharmacological method effects (Comfort)
timeFrame: [Time Frame: Perianesthesia Comfort Scale (PCS) will be applied after the catheter withdrawal process is completed. PCS measurement will be take at approximately 40th minute.]
measure: Nonpharmacological method effects (Vital signs-Systolic and diastolic blood pressure mmHg)
timeFrame: [Time Frame: Systolic and diastolic blood pressures, which are vital signs of the patients, will be recorded at the 0th minute before the catheter extraction, at the 20th minute during and 40th minute afterward.]
measure: Nonpharmacological method effects (Vital signs-Respiratory rate per minute)
timeFrame: [Time Frame: Respiratory rate per minute, which are vital signs of the patients, will be recorded at the 0th minute before the catheter extraction, at the 20th minute during and 40th minute afterward.]
measure: Nonpharmacological method effects (Vital signs-Heart rate per minute)
timeFrame: [Time Frame: Heart rate per minute, which are vital signs of the patients, will be recorded at the 0th minute before the catheter extraction, at the 20th minute during and 40th minute afterward.]
Secondary outcomes:
measure: Nonpharmacological method effects (pain)
timeFrame: [Time Frame: Secondary VAS pain measurement will be performed at approximately 40th minutes after catheter removal.
measure: Nonpharmacological method effects (Anxiety)
timeFrame: Time Frame: The secondary SAI measurement will be made approximately 40th minutes after the catheter withdrawal process of all groups is completed.
Other outcomes:
Locations:
city: Sarıçam
country: Turkey
facility: Cukurova University
state: Adana
Study officials:
References: