Clinical trial NCT05692193: The Effect of Pain Education on Pain and Comfort
Official title: The Effect Of Pre-Surgery Paın Educatıon On Postoperatıve Paın And Comfort In Anorectal Dıseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Anorectal diseases
pain
confort
Pain education
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study was planned as quasi-experimental to determine the effect of pain training given to patients who will undergo surgery for anorectal diseases on postoperative pain and comfort. The research was carried out in Istanbul Taksim Training and Research Hospital General Surgery Clinic between November 2021 and November 2022. Data were collected with the "Patient Introduction Education Leaflet", "Patient Pain Education Leaflet", "Numeric Pain Scale", "Brief Pain Inventory" and "Perianesthesia Comfort Scale". The data were analyzed with appropriate statistical methods using the SPSS 25.0 package program.

In the study, the difference between the groups in terms of demographic characteristics and life histories of the patients was insignificant and showed a homogeneous distribution (p\>0.05). When the measurements of the patients in the experimental and control groups were compared; It was determined that the patients in the experimental group had lower pulse, blood pressure, respiratory rate and body temperature, and the mean SPO2 was higher than the patients in the control group (p\<0.05). When the evaluations between the groups are examined; It was found that the mean pain scores evaluated with the Numerical Pain Scale and Brief Pain Inventory scales in the patients included in the experimental group were lower than the patients included in the control group; The comfort level evaluated with the Perianesthesia Comfort Scale was found to be higher in the experimental group than in the control group (p\<0.05).

Hypothesis 1: Pain education given to experimental group patients who will undergo surgery for anorectal diseases has an effect on postoperative pain.

Hypothesis 2: Pain education given to patients in the experimental group who will undergo surgery for anorectal diseases has an effect on the comfort level after surgery.

Detailed description: Type of research: The research was planned as quasi-experimental. Location: The study is planned to be carried out with patients who were planned for anorectal surgery and hospitalized in Taksim Training and Research Hospital General Surgery Clinic in Beyoğlu district of Istanbul.

Population, sampling method and number: The population of the study will consist of patients who will undergo hemorrhoid, anal abscess, anal fissure or anal fistula surgery in the General Surgery Clinic in Taksim Training and Research Hospital in Istanbul.

There are different methods to determine the sample size in the literature. In this study, the sample size for repeated ANOVA measures will be calculated using the medium effect size standardized by Cohen. Sample calculation will be done with G-power 3.1 package program. The sample of the study will be determined as at least 36 patients in each of the case and control groups, with an effect size of 0.25 and a power of 0.90. Considering that there may be case losses due to any reason and cases that can be excluded from the sample in terms of homogeneity of the groups, it will be planned to include 40 patients in the study and control groups by increasing it by 10%. Being over 18 years old, being literate, having surgery for anorectal diseases, having surgery under spinal anesthesia and volunteering to participate in the study will be determined as inclusion criteria.

Dependent Variables: Heart rate, respiratory rate, oxygen saturation, body temperature, blood pressure, pain score constitute the dependent variables.

Independent Variables: Gender, age, weight, height, occupation, income level and previous surgeries constitute the independent variables.

Statistical analysis methods to be used: The data obtained from the research will be transferred to the electronic environment and evaluated in the SPSS 25.0 package program. Number, percentage, mean and standard deviation will be used as descriptive statistical methods in the evaluation of the data. Before the data analysis, normality test will be done to test the compliance with the parametric test methods. In order to test the normal distribution condition, Kolmogorov Smirnov Z test will be applied. Chi-square and Fisher's exact tests will be applied to determine the homogeneity of the groups. In line with the results, the data will be analyzed with the related tests. The findings will be evaluated at the 95% confidence interval and at the 5% significance level.

In order to obtain the data of the study, "Patient Identification Form", "Patient Pain Education Brochure", "Numerical Pain Scale" , "Short Pain Inventory" prepared by the researcher by scanning the literature., "Perianesthesia Comfort Scale" will be used. In the quasi-experimental study, the patients will be divided into two groups as the experimental and control group by simple random method. The patients in the experimental group will be given the "Patient Pain Education Brochure" prepared one day before the surgery, taking into account the individual and pandemic measures, and at the same time, the training will be given verbally and in writing for an average of 20-30 minutes in the patient's own room. With the patient's vital signs at the time of admission to the ward before the training, immediately after the training and at the 15th, 30th, 45th, 60th minutes, 2nd, 4th, 6th, 12th, and 24th hours after the operation, to the intervention group that was trained. "Numerical Pain Scale", "Brief Pain Inventory" , "Perianesthesia Comfort Scale" will be applied at the 24th hour. Patients in the control group will not be given pain training, and vital signs of the patient during their hospitalization, one day before the operation and at the 15th, 30th, 45th, 60th minutes, 2nd, 4th, 6th, 12th, 24th hours after the operation. "Numerical Pain Scale" , "Brief Pain Inventory" , "Perianesthesia Comfort Scale" will be applied at the 24th hour. The patients will be informed about the purpose of the research, benefits, duration of education, scale forms and evaluation periods by the researcher, and an "Informed Consent" will be obtained by explaining that their individual rights will be protected and their personal information will be kept confidential. The patient education brochure will be submitted to the expert opinion of 10 people for content evaluation. The brochure will be finalized according to the suggestions of the experts. The prepared training will be applied to 10 patients for content and language validity.

Eligibility criteria: Inclusion Criteria:

- Being over 18 years old, literate, having surgery for anorectal diseases, having surgery under spinal anesthesia and volunteering to participate in the research.

Exclusion Criteria:

* using analgesia, mentally ill

Primary outcomes:
measure: Pain score
timeFrame: Hospitalization day (0. minute)
measure: Pain Score
timeFrame: 15 minutes after surgery
measure: Pain Score
timeFrame: 30 minutes after surgery
measure: Pain Score
timeFrame: 45 minutes after surgery
measure: Pain Score
timeFrame: 60 minutes after surgery
measure: Pain Score
timeFrame: 120 minutes after surgery
measure: Pain Score
timeFrame: 4. hours after surgery
measure: Pain Score
timeFrame: 6. hours after surgery
measure: Pain Score
timeFrame: 12. hours after surgery
measure: Pain Score
timeFrame: 24. hours after surgery
Secondary outcomes:
measure: Comfort level
timeFrame: 24. hours after surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Home
state: Üskudar
Study officials:
affiliation: Istanbul Taksim Training and Research Hospital
name: Muhsin Uysal, Researcher
role: PRINCIPAL_INVESTIGATOR
References: