Pain Due to Peripheral Intravenous Catheter Insertion

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: rose oil aromatherapy

• Registration Number: NCT05425849
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

This study aimed to evaluate the effectiveness of rose oil aromatherapy and hand-holding in reducing pain associated with peripheral intravenous catheters (PIVCs) insertion.

Study Hypothesis:

H0-1. The application of rose oil aromatherapy during the PIVC insertion procedure does not reduce the pain associated with the procedure.

H0-2. During the PIVC insertion procedure, the patient's family holding the patient's hand does not reduce the pain associated with the procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-10
• Primary Completion: 2021-09-10
• Study Completion: 2021-09-10
• Status Verified: 2022-06
• Study First Submitted: 2022-06-11
• Study First Submitted QC: 2022-06-15
• Last Update Submitted: 2022-06-20
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• patients voluntarily accepted to participate in the study,
• aged between 18-65,
• Turkish literate,
• PIVC placement planned,
• no hematoma, ecchymosis, scar and sensory change in the antecubital region,
• suitable for PIVC insertion with a 20 gauge (pink) catheter in the antecubital region,
• who did not take analgesic drugs for 24 hours and were accompanied by a member of the patient's family (spouse or child).
• patients with an Enhanced Adult DIVA (EA-DIVA) score below 8 for PIVC placement in a single intervention,
• the STAI score below 40

Exclusion Criteria

• sensitive to smell and had problems in smelling,
• patients with epilepsy, asthma diagnosis,
• patients with a history of allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hand holding group	rose oil aromatherapy	After the patients in the hand-holding group were placed in a sitting position, the patient's family was asked to hold the patient's hand and not let it go until the procedure was over. Standard PIVC insertion procedure was applied.
rose oil group	rose oil aromatherapy	After the patients in the rose aromatherapy group were placed in a sitting position, a face mask with 1-2 drops of rose oil was placed on the nose area. Then, the standard PIVC insertion procedure was applied. After the procedure, the patient's rose-scented mask was replaced with a standard mask.

Primary Outcome Measures

Name	Time	Method
Pain Score	1 minute-10 minutes	Numeric Rating Scale was used. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)

Trial Locations

Locations (1)

Tulay Basak; 🇹🇷 Ankara, Turkey