Clinical trial NCT06445387: Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Coronary Intervention
Virtual Reality
Nursing Caries
Cryotherapy
Pain Management
Keywords: Percutaneous Coronary Intervention
Virtual Reality
Pain Management
Nursing
Ice Application
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Pain Scores: Numerical rating scale
timeFrame: "through study completion, an average of 1 year".
Secondary outcomes:
measure: Physiological parameter
timeFrame: "through study completion, an average of 1 year".
measure: Physiological parameter
timeFrame: "through study completion, an average of 1 year".
measure: Physiological parameter
timeFrame: "through study completion, an average of 1 year".
measure: Physiological parameter
timeFrame: "through study completion, an average of 1 year".
Other outcomes:
measure: Questionnaire
timeFrame: "through study completion, an average of 1 year".
Locations:
city: Amasya
country: Turkey
facility: Amasya University İnstitute of Health Sciences
state: Merkez
Study officials:
affiliation: Amasya University Faculty of Health Science
name: Eylem Topbaş, Phd
role: STUDY_DIRECTOR
affiliation: Amasya University Faculty of Medical Science
name: Gökhan KESKİN, Phd
role: STUDY_DIRECTOR
affiliation: Amasya University Instutue of Health Science
name: Aycan SOYLU, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.