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Completed

NCT Number: NCT05425849

Pain Due to Peripheral Intravenous Catheter Insertion

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tulay Basak

Ankara, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: handholding

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2022
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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