The Effect of Traction-Pressure-Release (TPR) and Manual Pressure Methods on Intramuscular Injection Pain and Satisfaction in Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Pain intensity after intramuscular injection
研究概览
简要总结
The goal of this clinical trial is to evaluate whether two different intramuscular (IM) injection techniques-Manual Pressure and Traction-Pressure-Release (TPR)-can effectively reduce injection-related pain and improve patient satisfaction in adult hospitalized patients receiving diclofenac sodium (3 mL) via IM injection.
The main questions the study aims to answer are:
Does the TPR technique reduce IM injection pain more effectively than the standard method?
Does the Manual Pressure technique reduce IM injection pain more effectively than the standard method?
How are patients' fear of injection and experienced pain related?
Since there is a comparison group, researchers will compare three arms (Control, Manual Pressure, TPR) to determine whether either technique results in lower pain scores and higher satisfaction compared with the standard IM injection procedure.
Participants will:
Receive diclofenac sodium via IM injection in the ventrogluteal site using one of three randomized techniques:
- Standard IM injection (Control)
- Manual Pressure technique
- Traction-Pressure-Release (TPR) technique
Rate their pain using the Visual Analog Scale (VAS) immediately after the injection.
Rate their satisfaction using the Injection Satisfaction Scale.
Provide demographic and clinical data through a Patient Information Form.
This study uses a single-blind randomized controlled trial design with three parallel groups. A total of 174 adult patients will be enrolled to ensure adequate power for statistical comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Age ≥ 18 years.
- •Hospitalized in the Orthopedics, General Surgery, or Orthopedics Clinic at Servergazi State Hospital.
- •Prescribed intramuscular diclofenac sodium (3 mL).
- •Has not received any intramuscular injection in the previous week.
- •Able to understand instructions and accurately use the Visual Analog Scale (VAS).
- •Provides written informed consent.
排除标准
- •Presence of pain, abscess, infection, tissue necrosis, hematoma, or any complication related to previous intramuscular injections at the ventrogluteal site.
- •Impaired consciousness or communication difficulties.
- •Visual or hearing impairment that prevents accurate scale assessment.
- •Any physical condition preventing proper positioning of the extremities for IM injection.
- •Declines to participate or withdraws consent at any time.
结局指标
主要结局
Pain intensity after intramuscular injection
时间窗: Immediately after injection (within 1-2 minutes)
Pain intensity will be measured using the 100-mm Visual Analog Scale (VAS), where 0 indicates "no pain" and 100 indicates "worst imaginable pain." Participants will mark their pain level immediately after the intramuscular injection. The distance (mm) from the left end of the scale to the participant's mark will be recorded as the pain score.
次要结局
- Injection satisfaction level(Immediately after injection (within 1-2 minutes))
- Relationship between fear of injection and experienced pain(Immediately after injection)
研究者
Melek Sahin
Assistant Professor
Muğla Sıtkı Koçman University