Pain Due to Peripheral Intravenous Catheter Insertion

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05425849
• Other study ID #: 394
• Status: Completed
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: June 2022
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Tulay Basak	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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