Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05756140 |
| Other study ID # |
2022-16-09 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Zonguldak Bulent Ecevit University |
| Contact |
Tülin KURT ALKAN, Expert |
| Phone |
+905393711902 |
| Email |
tulinkurt0[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
By integrating the methods used in the assessment of pain in geriatric surgery patients with
literature, theory and research, this study aims to: evaluate the effectiveness of the facial
diagnosis system in the evaluation of pain after geriatric surgery.
The research hypotheses are as follows:
H1: In the evaluation of pain after geriatric surgery, there is a concordance between the
pain score evaluated by the patient and the pain score obtained from facial expression
diagnostic system analysis.
H1: In the evaluation of pain after geriatric surgery, there is a correlation between the
pain score evaluated by the nurse and the pain score obtained from the analysis of the facial
expression diagnosis system.
H1: In the evaluation of pain after geriatric surgery, there is a correlation between the
pain score evaluated by the patient and the pain score evaluated by the nurse.
Description:
By integrating the methods used in the assessment of pain in geriatric surgery patients with
literature, theory and research, this study aims to: evaluate the effectiveness of the facial
diagnosis system in the evaluation of pain after geriatric surgery.
The number of patients in the groups will be analyzed based on one of the studies to be used
in the study. According to the calculations made in the G-Power 3.1 Demo package program,
when the effect size is accepted as 0.8, it was seen that at least 68 patients would be
sufficient for 80% power. In this way, the criteria sampling method will be used. Anticipated
duration is one year.
The inclusion criteria of the patients in the study are as follows:
- The patient is 65 years or older,
- According to the American Society of Anesthesiologists (ASA) classification; Being in
class II and III; ASA II: Patient with mild systemic disease, ASA III: Patient with
severe systemic disease but not affecting activities of daily living.
- Willingness to participate in the research,
- The patient is awake and oriented after the surgery,
- The patient is not discharged within the first 24 hours after the operation,
Data collecting:
1. An informed consent form will be obtained from patients over 65 years of age in the
postoperative period who agreed to participate in the study.
2. Then, the Sociodemographic Data Collection Form created by the researcher will be
filled. Sociodemographic form; patient's age, gender, presence of chronic disease,
history of surgery, clinical diagnosis of the patient, the patient's surgery, anesthesia
during the operation, the patient's ASA score, the nurse's age, the nurse's gender, the
nurse's education level, the nurse's clinical experience, the severity of pain felt by
the elderly adult patient.
3. After the surgery, when the patient comes to the service and 1 hour after coming to the
service, the 3rd and later stages will be repeated. In other words, the patient's pain
will be evaluated 2 times in total. The patient and nurse will then be asked to give
patient a pain score. Two scales will be used in pain assessment. These are Wong Baker
Faces Pain Scale and Numerical Rating Scale.Wong Baker Faces Pain Scale: It consists of
6 different facial expressions, starting with a smiling face and ending with a crying
face. Numerical Rating Scale: Patients are asked to draw a number from 0 to 10, 0 to 20,
or 0 to 100 that best fits pain intensity. Zero usually indicates "no pain", while the
upper limit represents "unbearable pain".
4. And the patient's 30-second facial expression will be recorded with a video camera.
5. This video recording and the score given by the patient will be uploaded to the computer
and the pain score.
6. The resulting value will be compared with the value given by the nurses.
