Pain Due to Peripheral Intravenous Catheter Insertion

June 20, 2022 updated by: Tulay Basak, Saglik Bilimleri Universitesi

The Effect of Rose Oil Aromatherapy and Hand-Holding on Pain Due to Peripheral Intravenous Catheter Insertion: A Mixed Method Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Tulay Basak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
No attempt was made to reduce pain in the patients in the control group. Standard PIVC insertion procedure was applied.
Experimental: rose oil group
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
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
Other Names:
  • handholding
Experimental: hand holding group
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
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
Other Names:
  • handholding

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2021

Primary Completion (Actual)

September 10, 2021

Study Completion (Actual)

September 10, 2021

Study Registration Dates

First Submitted

June 11, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on rose oil aromatherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe