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Completed

NCT Number: NCT06445387

Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amasya University İnstitute of Health Sciences

Amasya, Merkez, 05100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Experimental

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.

Other names: Experimental

Control Group

Other

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

Other names: Control

Primary outcomes

  1. Pain Scores: Numerical rating scale

    Time frame: "through study completion, an average of 1 year".

    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).

Secondary outcomes

  1. Physiological parameter

    Time frame: "through study completion, an average of 1 year".

    Vital parameters (Pulse rate measured in minutes) of the patients were evaluated

    Pulse rate was measured before femoral sheath removal (time 1) Pulse rate was measured during femoral sheath removal (2nd time) Pulse rate was measured immediately after femoral sheath removal (3rd time) Pulse rate was measured 30 minutes after femoral sheath removal (4th time) Pulse rate was measured 1 hour after femoral sheath removal (5th time

  2. Physiological parameter

    Time frame: "through study completion, an average of 1 year".

    Vital parameters (respiration-rate measured in minutes) of the patients were evaluated.

    Respiration rate was measured before femoral sheath removal (time 1) Respiration rate was measured during femoral sheath removal (2nd time) Respiration rate was measured immediately after femoral sheath removal (3rd time) Respiration rate was measured 30 minutes after femoral sheath removal (4th time) Respiration rate was measured 1 hour after femoral sheath removal (5th time)

  3. Physiological parameter

    Time frame: "through study completion, an average of 1 year".

    Vital parameters (blood pressure-measured in mmHg) of the patients were evaluated

    Blood pressure was measured before femoral sheath removal (time 1) Blood pressure was measured during femoral sheath removal (2nd time) Blood pressure was measured immediately after femoral sheath removal (3rd time) Blood pressure was measured 30 minutes after femoral sheath removal (4th time) Blood pressure was measured 1 hour after femoral sheath removal (5th time)

  4. Physiological parameter

    Time frame: "through study completion, an average of 1 year".

    Vital parameters (body temperature measured in degrees Centigrant) of the patients were evaluated

    Body temperature was measured before femoral sheath removal (time 1) Body temperature was measured during femoral sheath removal (2nd time) Body temperature was measured immediately after femoral sheath removal (3rd time) Body temperature was measured 30 minutes after femoral sheath removal (4th time) Body temperature was measured 1 hour after femoral sheath removal (5th time)

Other outcomes

  1. Questionnaire

    Time frame: "through study completion, an average of 1 year".

    The patients' opinions regarding the application of ice and virtual reality glasses were evaluated.

Sponsors and collaborators

Lead sponsor

Amasya University

Other

Registry information

Official study title

The Effect of Virtual Reality Glasses and Ice Applıcatıon on the Level of Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 6, 2024
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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