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临床试验/NCT05425849
NCT05425849已完成不适用

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

Saglik Bilimleri Universitesi2 个研究点 分布在 2 个国家目标入组 126 人开始时间: 2021年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
2
主要终点
Pain Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Pain Score

时间窗: 1 minute-10 minutes

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tulay Basak

Professor

Saglik Bilimleri Universitesi

研究点 (2)

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