Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion

NCT ID: NCT06445387

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2023-01-04

Brief Summary

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

Detailed Description

After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (virtual reality glasses application, ice application and control group).

Randomization: Since the number of male and female patients was wanted to be kept equal, simple randomization would not be possible, so the stratified randomization method was used.

Patients were assigned to groups in equal numbers according to their femoral sheath sizes. In our clinic, size 6 and 7 femoral sheaths are applied to male patients, and number 6 femoral sheaths are applied to female patients. Male patients were assigned to equal groups according to femoral sheath size 6 and 7.

Since PCI is not performed in our clinic on weekends except for emergencies, data were collected during working hours during a five-day weekday period.

The pain level of the patients was evaluated using a numerical rating scale;

• before the femoral sheath extraction (PAS1),
• during the femoral sheathing (SDQ2),
• immediately after the femoral sheathing (SDQ3),
• 30 minutes after the femoral sheathing (SDQ4) and
• 1 hour after the femoral sheathing (SDQ4). SDÖ5) was evaluated and recorded.

Conditions

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

Study Design

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

Study Groups

Virtual Reality Glasses Gruop

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.

Group Type: EXPERIMENTAL

Virtual Reality Glasses

Intervention Type: 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.

Ice Application Group

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.

Group Type: EXPERIMENTAL

Ice Application Group

Intervention Type: 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.

Control Group

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

Group Type: OTHER

Control Group

Intervention Type: OTHER

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

Interventions

Virtual Reality Glasses

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.

Intervention Type: OTHER

Ice Application Group

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.

Intervention Type: OTHER

Control Group

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

Intervention Type: OTHER

Other Intervention Names

Experimental; Experimental; Control

Eligibility Criteria

Inclusion Criteria

• 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,

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amasya University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eylem Topbaş, Phd

Role: STUDY_DIRECTOR

Amasya University Faculty of Health Science

Gökhan KESKİN, Phd

Role: STUDY_DIRECTOR

Amasya University Faculty of Medical Science

Aycan SOYLU, Msc

Role: PRINCIPAL_INVESTIGATOR

Amasya University Instutue of Health Science

Locations

Amasya University İnstitute of Health Sciences

Amasya, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 15297952 (View on PubMed)

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.

Reference Type: RESULT

PMID: 9145556 (View on PubMed)

Other Identifiers

AU-SBE-ASoylu-03

Identifier Type: -

Identifier Source: org_study_id