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临床试验/NCT06635031
NCT06635031已完成不适用

Assessment of the Relationship Between Sense of Coherence and the Healing of Surgery-related Intraoral Wound by Using a Novel Scale: A Clinical Randomized Study.

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年11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
160
试验地点
1
主要终点
Evaluation of Sence of Coherence

研究概览

简要总结

The study aimed to investigate the relationship between sence of coherence (SOC) and surgery-related oral wound healing.

The study was consisted of one hundred and sixty patients of both sexes (female,male) who were scheduled for oral surgery. Pre-operatively the patients were asked to complete a questionnaire designed to measure their Sense of Coherence (SOC). The wound healing was evaluated after 4 days, 14 days and 6 weeks after surgical operation. The results were analyzed statistically.

详细描述

Many factors play a role in wound healing (WH) including physiologic factors. The concept of Sense of Coherence (SOC), reflects an individual's capacity to respond to stressful situations. High SOC scores indicate a strong SOC, and individuals with strong SOC are reported to tolerate stress better. Additionally, a strong SOC has been associated with fewer symptoms and significantly fewer issues related to oral condition. The aim of this study is to evaluate the relationship between SOC and wound healing following oral surgery. The study included 160 patients of both sexes (female,male). An informed consent form was obtained from all participants. Pre-operatively the patients were asked to complete a questionnaire designed to measure their Sense of Coherence (SOC). A blinded operator, who was not involved in the operation, recorded all data of the patients pre-operatively. All patients were undergone oral surgery. All surgical procedures were performed by the second maxillofacial surgeon. The first blinded operatoand conducted postoperative measurements. The wound healing was evaluated after 4 days, 14 days and 6 weeks after surgical operation. To evaluate of wound healing, a scale named Inflammatory Proliferative Remodeling (IPR) Scale was used. According to this scale, patients were recalled 3 days, 14 days and 6 weeks after surgical operation. The third blinded researcher was responsible for the analysis data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adult patients aged between 18-65 years
  • Patients classified as American Society of Anesthesiologists (ASA) physical status ASA I
  • Patients scheduled to undergo oral surgery

排除标准

  • Not consenting to participate
  • Intake of steroid, bisphosphonate or immune-suppressive medication
  • Receiving radiotherapy in the head and neck area
  • Pregnancy
  • Inability to self-evaluate, and inability to communicate verbally and in writing.

结局指标

主要结局

Evaluation of Sence of Coherence

时间窗: 6 weeks

Sence of Coherence (SOC) was measured using a 13-question survey, where participants rate their answers on a scale from 1 to 7, with 1 representing "never" and 7 indicating "very often." Total scores above 45 are regarded as indicative of high SOC values.

Evaluation of Oral Wound Healing

时间窗: 6 weeks

Wound Healing (WH) was assessed by using a scale called Inflammatory Proliferative Remodeling (IPR) Scale. According to the scale, each phase of the healing is scored based on the parameters, including edema, bleeding, swelling. The total score of the IPR scale ranges from 0 to 16; 0-4 indicates poor healing; 5-10, acceptable healing; and 11-16, excellent healing.

次要结局

  • Evaluation of post-operative pain(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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