Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion

NCT06445387 | Completed

• 1 other identifier: AU-SBE-ASoylu-03
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

It is to examine the effect of virtual reality and ice application on the pain level due to femoral sheath extraction.

Conditions

Percutaneous Coronary Intervention; Virtual Reality; Nursing Caries; Cryotherapy; Pain Management

Keywords

Percutaneous Coronary Intervention; Virtual Reality; Pain Management; Nursing; Ice Application

Outcome Measures

Primary Outcomes (1)

• Pain Scores: Numerical rating scale

  The Numeric Rating Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a min:0-max:10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" (10). This scale is a valid and reliable scale developed to determine the pain level of patients. The numerical rating scale simplifies the description of the pain level by the patient and makes it easier for the monitoring nurse to record the patient's pain rating. That the pain increases as the score increases, and then the patient verbally tells the numerical value of the pain intensity he/she feels. Pain score was measured before femoral sheath removal (time 1), and, during femoral sheath removal (2nd time),and, immediately after femoral sheath removal (3rd time), and 30 minutes after femoral sheath removal (4th time), and1 hour after femoral sheath removal (5th time).

  "through study completion, an average of 1 year".

Secondary Outcomes (4)

• Physiological parameter

  "through study completion, an average of 1 year".

• Physiological parameter

  "through study completion, an average of 1 year".

• Physiological parameter

  "through study completion, an average of 1 year".

• Physiological parameter

  "through study completion, an average of 1 year".

Other Outcomes (1)

• Questionnaire

  "through study completion, an average of 1 year".

Study Arms (3)

Virtual Reality Glasses Gruop

EXPERIMENTAL

The procedure was tested for five minutes, one hour before application, to evaluate the patients' compliance and to detect any possible problems after wearing the glasses. In patients who did not experience any problems after the test, glasses were put on the patient just before the femoral sheath and remained on for 20 minutes.

Other: Virtual Reality Glasses

Ice Application Group

EXPERIMENTAL

Before taking the femoral sheath, the researcher applied cold to the area where the femoral sheath was located with an ice pack for 20 minutes. A femoral sheath was performed immediately after the ice bag was removed.

Other: Ice Application Group

Control Group

OTHER

The general procedure of the clinic was applied to the control group. Femoral sheath was removed without any invasive procedure.

Other: Control Group

Interventions

Virtual Reality Glasses OTHER

Preparation Stage of Virtual Glasses: A 20-minute video consisting of nature scenes shot with a 360-degree camera was selected by the researchers from YouTube. Permission was obtained from the person who created the video. For the selection of music, both the music that is good for diseases were examined in the literature and an expert opinion was taken from a faculty member (Phd, assistant professor) working at the Faculty of Music and Fine Arts of a university. The music used in the video was created with works selected from the Hüseyni maqam.

Also known as: Experimental

Virtual Reality Glasses Gruop

Ice Application Group OTHER

Features of the ice and ice bag used for patients in ice application; Ice cubes with dimensions of 9.5 x 26 x 3.5 cm were used. The ice bag is made of cotton and polyester coated fabric and is easily bendable. In this way, the ice bag was ensured to fit properly to the patient's femoral region. It is reusable and heat insulated. The procedure was carried out by following the cold application step protocol created by the researchers using the literature.

Also known as: Experimental

Ice Application Group

Control Group OTHER

They continued to receive their routine treatment and care. No changes were made in their routine treatment and care.

Also known as: Control

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: There were equal numbers of men and women in all three groups
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intervention in the femoral region,
• Femoral sheath size is 6-7 fr,
• Presence of only one sheath in the femoral region,
• No analgesics were administered before femoral sheath removal,
• Absence of serious bleeding and major hematoma in the femoral region,
• Being over 18 years of age,
• No communication problems,
• Having a place and time orientation,
• No dizziness,
• Not having any psychiatric disease,
• No visual, auditory or mental problems,
• No previously identified cold allergy,
• Being willing and willing to participate in the study,

You may not qualify if:

• Serious bleeding and major hematoma development in the femoral region,
• Not applying intracoronary stent or coronary angioplasty after coronary angiography,
• Vital signs are abnormal enough to prevent intervention,
• Having visual, auditory and mental disabilities,
• Having a communication problem,
• Not being willing and able to participate in the study,
• It is defined as wanting to withdraw from the study at any stage of the study or being excluded from the study by the researcher.

Sponsors & Collaborators

• Amasya University: lead

Study Sites (1)

Amasya University İnstitute of Health Sciences

Amasya, Merkez, 05100, Turkey (Türkiye)

Location

Related Publications (2)

• Wang HL, Keck JF. Foot and hand massage as an intervention for postoperative pain. Pain Manag Nurs. 2004 Jun;5(2):59-65. doi: 10.1016/j.pmn.2004.01.002.

  PMID: 15297952 RESULT

• Paice JA, Cohen FL. Validity of a verbally administered numeric rating scale to measure cancer pain intensity. Cancer Nurs. 1997 Apr;20(2):88-93. doi: 10.1097/00002820-199704000-00002.

  PMID: 9145556 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Eylem Topbaş, Phd

  Amasya University Faculty of Health Science

  STUDY DIRECTOR

• Gökhan KESKİN, Phd

  Amasya University Faculty of Medical Science

  STUDY DIRECTOR

• Aycan SOYLU, Msc

  Amasya University Instutue of Health Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is a randomized controlled, single-blind, experimental study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a randomized controlled, single-blind, experimental study. Participants were assigned to three groups: intervention (virtual reality group and ice group) and control group.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 6, 2024
• Study Start: July 12, 2021
• Primary Completion: November 3, 2022
• Study Completion: January 4, 2023
• Last Updated: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)