NCT05692193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 6, 2023

Last Update Submit

January 18, 2023

Conditions

Keywords

Anorectal diseasespainconfortPain education

Outcome Measures

Primary Outcomes (10)

  • Pain score

    Pain intensity is measured as a numerical pain scale (0 = no pain, 10 = excruciating pain). The degree of pain expressed by the individual measures the general activity state caused by the pain in the last 24 hours, emotional state, relationships with other people, ability to walk, exercise, sleep, and enjoyment of life. Each item is evaluated as a numerical pain scale from 0 to 10 (0 = not affected at all, 10 = completely affected). The patient can mark the area where he feels pain on the picture, which method or drugs are used to provide analgesia, and the level of describing the pain in the last 24 hours is evaluated with percentages. In the brief pain inventory, pain is defined as 1-4 mild pain, 5-6 moderate and 7-10 severe pain.

    Hospitalization day (0. minute)

  • Pain Score

    Pain intensity is measured as a numerical pain scale (0 = no pain, 10 = excruciating pain). The degree of pain expressed by the individual measures the general activity state caused by the pain in the last 24 hours, emotional state, relationships with other people, ability to walk, exercise, sleep, and enjoyment of life. Each item is evaluated as a numerical pain scale from 0 to 10 (0 = not affected at all, 10 = completely affected). The patient can mark the area where he feels pain on the picture, which method or drugs are used to provide analgesia, and the level of describing the pain in the last 24 hours is evaluated with percentages. In the brief pain inventory, pain is defined as 1-4 mild pain, 5-6 moderate and 7-10 severe pain.

    15 minutes after surgery

  • Pain Score

    Pain intensity is measured as a numerical pain scale (0 = no pain, 10 = excruciating pain). The degree of pain expressed by the individual measures the general activity state caused by the pain in the last 24 hours, emotional state, relationships with other people, ability to walk, exercise, sleep, and enjoyment of life. Each item is evaluated as a numerical pain scale from 0 to 10 (0 = not affected at all, 10 = completely affected). The patient can mark the area where he feels pain on the picture, which method or drugs are used to provide analgesia, and the level of describing the pain in the last 24 hours is evaluated with percentages. In the brief pain inventory, pain is defined as 1-4 mild pain, 5-6 moderate and 7-10 severe pain.

    30 minutes after surgery

  • Pain Score

    Pain intensity is measured as a numerical pain scale (0 = no pain, 10 = excruciating pain). The degree of pain expressed by the individual measures the general activity state caused by the pain in the last 24 hours, emotional state, relationships with other people, ability to walk, exercise, sleep, and enjoyment of life. Each item is evaluated as a numerical pain scale from 0 to 10 (0 = not affected at all, 10 = completely affected). The patient can mark the area where he feels pain on the picture, which method or drugs are used to provide analgesia, and the level of describing the pain in the last 24 hours is evaluated with percentages. In the brief pain inventory, pain is defined as 1-4 mild pain, 5-6 moderate and 7-10 severe pain.

    45 minutes after surgery

  • Pain Score

    Pain intensity is measured as a numerical pain scale (0 = no pain, 10 = excruciating pain). The degree of pain expressed by the individual measures the general activity state caused by the pain in the last 24 hours, emotional state, relationships with other people, ability to walk, exercise, sleep, and enjoyment of life. Each item is evaluated as a numerical pain scale from 0 to 10 (0 = not affected at all, 10 = completely affected). The patient can mark the area where he feels pain on the picture, which method or drugs are used to provide analgesia, and the level of describing the pain in the last 24 hours is evaluated with percentages. In the brief pain inventory, pain is defined as 1-4 mild pain, 5-6 moderate and 7-10 severe pain.

    60 minutes after surgery

  • Pain Score

    Pain intensity is measured as a numerical pain scale (0 = no pain, 10 = excruciating pain). The degree of pain expressed by the individual measures the general activity state caused by the pain in the last 24 hours, emotional state, relationships with other people, ability to walk, exercise, sleep, and enjoyment of life. Each item is evaluated as a numerical pain scale from 0 to 10 (0 = not affected at all, 10 = completely affected). The patient can mark the area where he feels pain on the picture, which method or drugs are used to provide analgesia, and the level of describing the pain in the last 24 hours is evaluated with percentages. In the brief pain inventory, pain is defined as 1-4 mild pain, 5-6 moderate and 7-10 severe pain.

    120 minutes after surgery

  • Pain Score

    Pain intensity is measured as a numerical pain scale (0 = no pain, 10 = excruciating pain). The degree of pain expressed by the individual measures the general activity state caused by the pain in the last 24 hours, emotional state, relationships with other people, ability to walk, exercise, sleep, and enjoyment of life. Each item is evaluated as a numerical pain scale from 0 to 10 (0 = not affected at all, 10 = completely affected). The patient can mark the area where he feels pain on the picture, which method or drugs are used to provide analgesia, and the level of describing the pain in the last 24 hours is evaluated with percentages. In the brief pain inventory, pain is defined as 1-4 mild pain, 5-6 moderate and 7-10 severe pain.

    4. hours after surgery

  • Pain Score

    Pain intensity is measured as a numerical pain scale (0 = no pain, 10 = excruciating pain). The degree of pain expressed by the individual measures the general activity state caused by the pain in the last 24 hours, emotional state, relationships with other people, ability to walk, exercise, sleep, and enjoyment of life. Each item is evaluated as a numerical pain scale from 0 to 10 (0 = not affected at all, 10 = completely affected). The patient can mark the area where he feels pain on the picture, which method or drugs are used to provide analgesia, and the level of describing the pain in the last 24 hours is evaluated with percentages. In the brief pain inventory, pain is defined as 1-4 mild pain, 5-6 moderate and 7-10 severe pain.

    6. hours after surgery

  • Pain Score

    Pain intensity is measured as a numerical pain scale (0 = no pain, 10 = excruciating pain). The degree of pain expressed by the individual measures the general activity state caused by the pain in the last 24 hours, emotional state, relationships with other people, ability to walk, exercise, sleep, and enjoyment of life. Each item is evaluated as a numerical pain scale from 0 to 10 (0 = not affected at all, 10 = completely affected). The patient can mark the area where he feels pain on the picture, which method or drugs are used to provide analgesia, and the level of describing the pain in the last 24 hours is evaluated with percentages. In the brief pain inventory, pain is defined as 1-4 mild pain, 5-6 moderate and 7-10 severe pain.

    12. hours after surgery

  • Pain Score

    Pain intensity is measured as a numerical pain scale (0 = no pain, 10 = excruciating pain). The degree of pain expressed by the individual measures the general activity state caused by the pain in the last 24 hours, emotional state, relationships with other people, ability to walk, exercise, sleep, and enjoyment of life. Each item is evaluated as a numerical pain scale from 0 to 10 (0 = not affected at all, 10 = completely affected). The patient can mark the area where he feels pain on the picture, which method or drugs are used to provide analgesia, and the level of describing the pain in the last 24 hours is evaluated with percentages. In the brief pain inventory, pain is defined as 1-4 mild pain, 5-6 moderate and 7-10 severe pain.

    24. hours after surgery

Secondary Outcomes (1)

  • Comfort level

    24. hours after surgery

Study Arms (2)

experimental group

EXPERIMENTAL

* A 'Patient Pain Education Brochure', which was prepared the day before the surgery, was given, and at the same time, the training was given verbally and in writing for an average of 20-30 minutes in the patient's own room. * Vital sessions and pain assessment were performed during admission to the ward before the training. * Pain was evaluated together with the patient's vital signs at the 15th, 30th, 45th, 60th minutes, 2nd, 4th, 6th, 12th, and 24th hours after the surgery. * Comfort assessment was performed at the 24th hour after surgery.

Behavioral: pain education

control group

NO INTERVENTION

* One day before the operation, vital signs and pain were evaluated during hospitalization. * Pain was evaluated together with the patient's vital signs at the 15th, 30th, 45th, 60th minutes, 2nd, 4th, 6th, 12th, and 24th hours after the surgery. * Comfort assessment was performed at the 24th hour after surgery.

Interventions

pain educationBEHAVIORAL

Pain education was given to the experimental group for 20-30 minutes on the day of hospitalization.

experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • using analgesia, mentally ill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Home

Istanbul, Üskudar, 34674, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeRectal DiseasesPain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Muhsin Uysal, Researcher

    Istanbul Taksim Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Nurse

Study Record Dates

First Submitted

January 6, 2023

First Posted

January 20, 2023

Study Start

November 1, 2021

Primary Completion

May 1, 2022

Study Completion

November 1, 2022

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations