Orthopedic DisorderNCT06104254
Education Importance and Pain Belief Differences Among Patients Who Underwent Orthopedic Surgery
A study testing education in people with Orthopedic Disorder and Post Operative Pain, run by Duzce University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Orthopedic Disorder, Post Operative Pain
- What is being tested?
- education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being over 18 years old.
- being conscious
- there have not any auditory and understanding problem
- being an elective surgery patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University Faculty of Health Science
Düzce, Düzce, 81000
About this study
Official title: Determining the Effect of Preoperative Education on Orthopedic Surgery Patients on Pain Beliefs and Pain-Related Care Needs in the Postoperative Period
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.
Read the detailed description
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.
Preoperative education is a significant component of the surgical process. Preoperative patient education is known to contribute to reduced postoperative pain and anxiety, as well as early discharge. Grä Sjöling et al. (2003) demonstrated in their study that preoperative education/information had an impact on postoperative pain scores. Furthermore, another study indicated that the majority of patients' greatest concern was the pain they might experience in the postoperative period. The information provided to patients about pain is associated with a high level of satisfaction. In this study, the aim is to determine the beliefs about postoperative pain and pain scores of patients undergoing orthopedic surgery following preoperative education. In this context, the study also aims to highlight the importance of involving patients in pain management and the preoperative patient education in the literature.
In this regard, the objective of the study is to examine the effects of postoperative mobilization times on patients' recovery status, pain levels, quality of life, and the development of complications after spinal surgery. By reporting the results of the study, it is anticipated that contributions will be made to the literature and that it will serve as a source for future research.
- Conditions
- Orthopedic Disorder, Post Operative Pain
- Being tested
- education
- Keywords
- post operative pain, pain beliefs, patient education
- Medical subject headings
- Musculoskeletal Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
we will give an education to experimental group about pain and pain management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: before operation and after surgery in the 30 days process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Nov 2023
- Primary completion15 Feb 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104254
- Sponsor's protocol ID
- ismailasatir
- Status last verified
- Jun 2024
- First submitted
- 23 Oct 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Preoperative Education on Orthopedic Surgery Patients on Pain Beliefs and Pain-Related Care Needs in the Postoperative Period
- ClinicalTrials.gov ID
- NCT06104254
- Acronym / sponsor ID
- ismailasatir
- Conditions
- Orthopedic Disorder, Post Operative Pain
- Keywords
- post operative pain, pain beliefs, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Preoperative education is a significant component of the surgical process. Preoperative patient education is known to contribute to reduced postoperative pain and anxiety, as well as early discharge. Grä Sjöling et al. (2003) demonstrated in their study that preoperative education/information had an impact on postoperative pain scores. Furthermore, another study indicated that the majority of patients' greatest concern was the pain they might experience in the postoperative period. The information provided to patients about pain is associated with a high level of satisfaction. In this study, the aim is to determine the beliefs about postoperative pain and pain scores of patients undergoing orthopedic surgery following preoperative education. In this context, the study also aims to highlight the importance of involving patients in pain management and the preoperative patient education in the literature.
In this regard, the objective of the study is to examine the effects of postoperative mobilization times on patients' recovery status, pain levels, quality of life, and the development of complications after spinal surgery. By reporting the results of the study, it is anticipated that contributions will be made to the literature and that it will serve as a source for future research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: educationThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being over 18 years old.
- being conscious
- there have not any auditory and understanding problem
- being an elective surgery patient
Key exclusion criteria (7 listed)
- Being under 18 years of age,
- being unconscious,
- Rheumatoid arthritis patients,
- Patients with mental illness,
- Patients using psychiatric drugs,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educationwe will give an education to experimental group about pain and pain management. | Other | experimental group |
Primary outcome
Pain level
Time frame: before operation and after surgery in the 30 days process
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).
Pain Beliefs
Time frame: before operation and after surgery in the 30 days process
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Orthopedic Disorder and Post Operative Pain, run by Duzce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: before operation and after surgery in the 30 days process). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.