NCT06104254

Brief Summary

The assessment of pain plays a crucial role in pain management. Nurses are instrumental in the identification, evaluation, and initiation of pain management strategies. In the literature, it is strongly recommended to provide education about postoperative pain management to patients, their families, and those responsible for patient care. Additionally, the development of a pain management plan and goals is advocated. The optimal timing, content, and objectives of patient education depend on the type of pain (acute or chronic), the availability and effectiveness of treatment, and the patient's level of education and literacy. Educating individuals undergoing elective surgery or outpatient treatment about the likelihood and magnitude of acute pain they may experience, as well as informing them about available methods to prevent or alleviate this pain, is critical for pain management. Shindo et al. conducted a study suggesting that perioperative pain education significantly reduces postoperative opioid use. According to the Health Belief Model, an individual's perception of health is influenced by their perception of the value of health, beliefs about illness, and beliefs about the consequences of illness. Therefore, when a patient's health beliefs and attitudes are determined, health education and treatment planning can be tailored more appropriately.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

October 23, 2023

Last Update Submit

June 26, 2024

Conditions

Keywords

post operative painpain beliefspatient education

Outcome Measures

Primary Outcomes (2)

  • Pain level

    we will use to measure patient pain level Numeric Pain Scale (NPS) several times. The intensity of pain will measure the area in which the individual mark between 0 (no pain) and 10 (worst pain i felt in my life).

    before operation and after surgery in the 30 days process

  • Pain Beliefs

    we will use to measure patient' pain belief with Pain Beliefs Questionnaire. Edwards and coworkers developed this survey to measure patients' pain beliefs in 1992. the survey has 12 questions. Likert-type scale items range from 1. (never) to 6 (always). An increase in the score obtained from the scale sub-dimension indicates a high pain belief in the sub-dimension, and a decrease in the score indicates a low pain belief in the relevant sub-dimension. Thanks to this survey we can measure both psychological and organic pain beliefs of patients. we will use the survey several times in different stages.

    before operation and after surgery in the 30 days process

Study Arms (2)

control group

NO INTERVENTION

The patient who assign to control group, they will give standard ward care before surgery and we measure their pain beliefs and pain level. After operation we will asses their pain beliefs and pain level. the last measure will be carried out after 30 days operation.

experimental group

EXPERIMENTAL

The patient who assign to experimental group, we will measure their pain beliefs and pain level before surgery. After that a researcher will give an education before operation to these patients about pain, potential pain and pain management after surgery. we will asses these patients pain beliefs and pain level after surgery and 30 days later again.

Other: education

Interventions

we will give an education to experimental group about pain and pain management.

experimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being over 18 years old.
  • being conscious
  • there have not any auditory and understanding problem
  • being an elective surgery patient

You may not qualify if:

  • Being under 18 years of age,
  • being unconscious,
  • Rheumatoid arthritis patients,
  • Patients with mental illness,
  • Patients using psychiatric drugs,
  • Patients with a known history of cancer
  • Patients requiring urgent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duzce University Faculty of Health Science

Düzce, Düzce, 81000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesPain, Postoperative

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 27, 2023

Study Start

November 1, 2023

Primary Completion

February 15, 2024

Study Completion

May 15, 2024

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations