The Relationship Between Sense of Coherence and Wound Healing.

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.

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.

Study Overview

• Status: Completed
• Conditions: Wound Heal; Sense of Coherence
• Intervention / Treatment: Procedure: Oral surgery

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

One hundred and sixty adult patients of both sexes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Sence of Coherence	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.	6 weeks
Evaluation of Oral Wound Healing	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of post-operative pain	To measure pain, participants were asked to describe their pain at follow-up appointments using a Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The numerical values obtained from these two scales were subjected to statistical analysis, to determine if there was a relationship between Sence of Coherence and post-operative pain.	6 weeks

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: ALANUR ÇİFTÇİ ŞİŞMAN, PhD, DDS, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Actual): March 10, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 23/77

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No