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临床试验/NCT07194252
NCT07194252尚未招募不适用

The Effect of Guided Imagery Applied Before and After Surgery on Surgical Anxiety, Pain, and Analgesic Consumption in Patients Undergoing Total Joint Arthroplasty: A Randomized Controlled Trial

Ankara Yildirim Beyazıt University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年9月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
128
试验地点
1
主要终点
Surgical Anxiety Scale

研究概览

简要总结

This randomized controlled study will investigate the effects of guided imagery on preoperative anxiety and postoperative pain and analgesic consumption in patients undergoing total joint arthroplasty. Conducted between September 2025 and June 2026 at a public hospital in Zonguldak, Turkey, the study will include patients scheduled for total joint arthroplasty following ethics committee approval. The intervention group will receive guided imagery twice preoperatively and once daily at 48 and 72 hours postoperatively. Outcomes will be assessed using the Surgical Anxiety Scale, surgery-specific anxiety scale, Numerical Rating Scale (NRS), and analgesic consumption tracking.

详细描述

This study aimed to investigate the effects of preoperative guided imagery on anxiety and postoperative guided imagery on pain intensity and analgesic consumption in patients undergoing total joint arthroplasty. This randomized controlled trial (RCT) study's population consisted of patients undergoing total joint arthroplasty at the Orthopedics and Traumatology Clinic of a public hospital in Zonguldak province between September 2025 and June 2026. The required sample size and power calculations for this study were performed using the G*Power program, with an effect size of 0.76 for the independent samples t-test. The minimum number of participants to provide 80% test power at a 95% confidence level was 58 for each surgical group, totaling 116 participants. The following data collection tools will be used: a "Descriptive Patient Information Form," a "Surgical Anxiety Scale," a "Surgery-Specific Anxiety Scale," a "Numerical Rating Scale (NRS)," and an "Analgesic Consumption Tracking Form." In the first stage, the "Descriptive Patient Information Form" will be administered to both the intervention and control groups. Then, surgical anxiety levels will be assessed using the "Surgical Anxiety Scale" and the "Surgery-Specific Anxiety Scale" in both the intervention and control groups. Guided imagery will then be administered to the intervention group twice preoperatively (in the afternoon and evening) one day before the scheduled surgery date and once at the 48th and 72nd hours postoperatively. At the end of the intervention, the "Surgical Anxiety Scale" and the "Surgery-Specific Anxiety Scale" will be administered again to the intervention group. In the postoperative period, the pain intensity of the intervention group will be measured with the "NRS" at the 48th and 72nd postoperative hours, before and immediately after the intervention. The surgical anxiety levels of the control group patients will be assessed simultaneously with the intervention group using the "Surgical Anxiety Scale" and "Surgery-Specific Anxiety Scale" without any intervention. In the postoperative period, the pain intensity of the control group will be measured with the "NRS" at the 48th and 72nd postoperative hours and will be measured again after these measurements simultaneously with the intervention group. Finally, the analgesic consumption of the intervention and control groups will be assessed on the 2nd and 3rd postoperative days using the "Analgesic Consumption Tracking Form," concluding the intervention phase. Microsoft-Excel 2019 and International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) 22.0 will be used for data analysis.

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
None

入排标准

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

入选标准

  • •Patients who have undergone unilateral arthroplasty surgery,
  • •Without cognitive impairment,
  • •Who speak and write Turkish,
  • •Without hearing or vision problems,
  • •Without any other acute illness causing pain or anxiety,
  • •Who received the same analgesic agent in the treatment protocol during the postoperative period,
  • •And who volunteered to participate in the study will be included.

排除标准

  • •Having a diagnosis of chronic pain syndrome or neuropathic pain,
  • •Having a diagnosis of psychiatric illness/being under treatment
  • •Continuous use of analgesic/sedative medication that may affect the pain threshold,
  • •Hearing impairment or severe cognitive impairment that prevents participation in guided imagery applications.

研究组 & 干预措施

intervention Grubs

Experimental

The intervention group's surgical anxiety levels were assessed using the "Surgical Anxiety Scale" during the preoperative period. Subsequently, at the relevant clinic, the scale was administered twice on the day before the scheduled surgery date (at noon and in the evening) and once each at 48 and 72 hours post-surgery, for a total of four times. At the end of the application, the "Surgical Anxiety Scale" and the "Surgical-Specific Anxiety Scale" will be reapplied to the intervention group. In the postoperative period, participants' pain intensity will be measured using the "NRS" at 48 hours postoperatively before the intervention, immediately after the intervention, and at 72 hours before the intervention and immediately after the intervention.

干预措施: Guided imagery technique application (Other)

Control Grubs

No Intervention

During the preoperative period, nursing care will be provided according to the routine care protocol of the clinic where the study is conducted. Subsequently, participants' levels of surgical anxiety will be assessed using the "Anxiety Scale Specific to Surgery" simultaneously with the intervention group patients. In the postoperative period, participants' pain intensity will be measured using the "NRS" at 48 and 72 hours postoperatively and will be measured again 60 minutes after the measurements (simultaneously with the intervention group patients). In the final stage, the analgesic consumption of the intervention and control groups will be evaluated on the 2nd and 3rd days of the postoperative period using the "Analgesic Consumption Tracking Form" to assess the administration status of the analgesic drugs included in the treatment protocol, and the application phase of the study will be completed.

结局指标

主要结局

Surgical Anxiety Scale

时间窗: September 2025-June 2026 (9 months)

The scale was developed in Turkish by Karanci and Dirik (2003) and is a 5-point Likert-type scale (1: Strongly disagree, 5: Strongly agree). The scale consists of 10 statements covering fears that patients may experience regarding surgery. The maximum score that can be obtained from the scale is 50. High scores on the scale reflect anxiety about experiencing pain, dying during surgery, and complications and restrictions that may arise after surgery. The Cronbach's Alpha coefficient for the scale was found to be 0.79.

次要结局

  • Numerical Rating Scale(September 2025-June 2026 (9 months))
  • Analgesic Consumption Tracking Form(September 2025-June 2026 (9 months))

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

BTuran

Lecturer

Zonguldak Bulent Ecevit University

研究点 (1)

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