Pain Due to Peripheral Intravenous Catheter Insertion

NCT05425849 | Completed

• 1 other identifier: 394
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Numeric Rating Scale was used. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)

  1 minute-10 minutes

Study Arms (3)

control group

NO INTERVENTION

No attempt was made to reduce pain in the patients in the control group. Standard PIVC insertion procedure was applied.

rose oil group

EXPERIMENTAL

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.

Other: rose oil aromatherapy

hand holding group

EXPERIMENTAL

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.

Other: rose oil aromatherapy

Interventions

rose oil aromatherapy OTHER

Aromatherapy refers to the medicinal or therapeutic use of essential oils absorbed through the skin or the olfactory system. The positive effects of social support, such as hand-holding, on anxiety and pain have been described

Also known as: handholding

hand holding group; rose oil group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Tulay Basak

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (1)

• Basak T, Demirtas A, Duman S. The effect of rose oil aromatherapy and hand-holding on pain due to peripheral intravenous catheter insertion. Explore (NY). 2024 Jan-Feb;20(1):62-69. doi: 10.1016/j.explore.2023.06.002. Epub 2023 Jun 7.

  PMID: 37301653 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 21, 2022
• Study Start: April 10, 2021
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)