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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06635031
Enrollment
160
Registered
2024-10-10
Start date
2023-11-10
Completion date
2024-05-01
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sense of Coherence, Wound Heal

Brief summary

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.

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.

Interventions

PROCEDUREOral surgery

The patients were undergone routine oral surgeries. Surgical procedures included an incision on the oral mucosa and full-thickness flap reflection, and the primary wound closure was achieved by polyglactin absorbable sutures.

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Oral Wound Healing6 weeksWound 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.
Evaluation of Sence of Coherence6 weeksSence 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.

Secondary

MeasureTime frameDescription
Evaluation of post-operative pain6 weeksTo 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026