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Fear of PainNCT05887596

The Effect of Patient Education on Pain

A study testing Patient education in people with Fear of Pain and Pain, run by Trakya University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: The study was conducted to determine the effect of patient education on pain level and fear of pain in orthopedics and traumatology patients Methods: The study is a randomized controlled experimental research design. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Fear of Pain, Pain, Pain Management
What is being tested?
Patient education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2021to 15 Mar 2022
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • open to communication and cooperation,
  • had no cognitive and mental problems,
  • volunteered to participate in the study

Who cannot join

  • closed to communication and cooperation,
  • had cognitive and mental problems,
  • not volunteered to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bakırköy Dr. Sadi Konuk Training and Research Hospital

    Istanbul, Bakırköy, 34140

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Patient Education on Pain Level and Fear of Pain in Orthopedians and Traumatology Patients

Objective: The study was conducted to determine the effect of patient education on pain level and fear of pain in orthopedics and traumatology patients Methods: The study is a randomized controlled experimental research design. Data were collected between December 15, 2021, and March 15, 2022 using the Information Form, Fear of Pain Scale-III, and Visual/Visual Analogue Scale. A total of 52 patients, 26 in the intervention group and 26 in the control group were included in the study. The intervention group received patient education about the operation process and pain management the day before and the morning of the operation day. Number Cruncher Statistical System and Statistical Software (Kaysville, Utah, USA) were used to analyse the data Keywords: Fear of Pain, Pain, Pain Management, Patient Education

Read the detailed description

Design The research is a randomized controlled experimental research design. Research hypotheses H1: The postoperative pain level of the patients in the intervention group is lower than that of the patients in the control group.

H2: The level of fear of postoperative pain of the patients in the intervention group is lower than that of the patients in the control group.

Research Variables Dependent Variables: Patients' pain level and fear of pain level Independent variable: Patient education Participants and setting The study group of the study consisted of 52 patients who underwent elective surgery in the orthopedics and traumatology clinic of the training and research hospital affiliated with the Ministry of Health in Istanbul between December 15, 2021, and March 15, 2022, and were open to communication and cooperation, had no cognitive and mental problems, and volunteered to participate in the study. The number of patients to be included in the study group; intervention and control were determined as a minimum of 25 patients (by calculating the margin of error of type 1 (α) = 0.05 and the power of the test (1-β) = 0.80, effect size 0.66 by power analysis of the patients constituting the universe). The study group consisted of a total of 52 patients, 26 in the intervention group and 26 in the control group, taking into account the possibility of data loss.

Intervention group: Patients receiving patient education on pain management Control group: Patients who did not receive training in pain management Patients who met the inclusion criteria were interviewed about the study. Patients who agreed to participate in the study were asked to choose an envelope containing an intervention or control letter. The patient with an intervention letter on the envelope was included in the intervention group and the patient with a control letter was included in the control group. Thus, bias in group selection was presented in the study.

Homogeneity between the groups was ensured by testing the gender, age, number of days of hospitalization, educational status, occupation, previous surgery, and regular use of pain medication. As a result of the analyses, it was found that there was no statistically significant difference between the gender, age, number of days of hospitalization, educational status, occupation, previous surgery, and regular use of pain medication in the intervention and control groups (p>0.05) (Table 1). According to the results, the intervention group (n: 26) and the control group (n: 26) showed homogenous distribution.

Data collection tools Data were collected using the Information Form, Fear of Pain Scale-III, and Visual/Visual Analogue Scale.

Information Form: The form, which was prepared by the researchers using the literature, includes 8 questions to determine the socio-demographic characteristics of the patients (gender, age, marital status, education level, occupation, number of days of hospitalization, previous surgery and regular medication use) (Büyükünal Şahin \& Rızalar, 2018; Yang et al, 2019).

Fear of Pain Scale-III: The scale was developed by McNeil and Rainwater in 1998 to measure the fear of pain. The scale was adapted into Turkish by Ünver and Turan (2018). The scale consists of 30 items and 3 sub-dimensions "Fear of Severe Pain", "Fear of Mild Pain" and "Fear of Medical Pain" with 10 items in each sub-dimension. The response options of the scale prepared in 5-point likert type are; "5-extreme, 4-very much, 3-quite, 2-somewhat, 1-never". 1-never feeling fear, the 5-excessive feeling of fear. All items in the scale are positive and there are no reversed items. The lowest score that can be obtained from the scale is 30 and the highest score is 150. The minimum score for the sub-dimensions is 10 and the maximum score is 50. The higher the scores obtained from the scale, the higher the fear of pain. The total Cronbach alpha internal consistency coefficient of the scale is 0.93, 0.88 for the fear of severe pain sub-dimension, 0.85 for the fear of mild pain sub-dimension, and 0.93 for the fear of medical pain sub-dimension (Ünver \& Turan, 2018).

Visual/Visual Analogue Scale: This scale is used to measure the level of pain. It is a one-dimensional scale. The scale is a 10 cm long ruler. It can be used horizontally or vertically. There are numbers from 0 to 10 on a scale of 0 (zero) "no pain" at one end and 10 (ten) "unbearable pain" at the other end. Pain level is measured by expressing the level of pain felt by the person with a numerical value from 0 to 10 (Eti Aslan \& Yıldız, 2017).

Data collection The research was conducted between December 15, 2021, and March 15, 2022. Firstly, the patients to be included in the intervention and control groups were determined. Information Form, Fear of Pain Scale-III was applied to the patients in both groups, and pain levels of the patients were measured with the Visual/Visual Analogue Scale. Patients in the intervention group received patient education about the operation process and pain management the day before and on the morning of the operation day. Patients in the control group also received patient education about the operation process on the preoperative day and the morning of the operation day. The education given to the intervention group included preoperative preparation, operating room environment, breathing exercises, cough exercises, etc. to be performed after surgery, non-pharmacological methods related to pain management (cold application, positioning, distraction), and pharmacological methods related to pain management. The training given to the control group included preoperative preparation, operating theatre environment, breathing exercises, cough exercises, etc. to be performed after surgery. In both groups, temperature, pulse rate, blood pressure, oxygen saturation level, and pain level with a Visual/Visual Analogue Scale were measured on the morning of the operation day, before the operation, every 4 hours for 24 hours after the operation and on the day of discharge. Again, pain fear level was measured with the Fear of Pain Scale-III on the day of discharge in both groups. It took approximately 20-25 minutes to complete the data collection tools.

Data analyses Number Cruncher Statistical System (NCSS) 2007 Software (Kaysville, Utah, USA) was used for data analysis. Descriptive statistical methods (mean, standard deviation, median, frequency, percentage, minimum, maximum) were used. The conformity of quantitative data to normal distribution was tested by the Shapiro-Wilk test and graphical analyses. Independent groups t-test was used for comparisons of quantitative variables with normal distribution between two groups, and the Mann-Whitney U test was used for comparisons of quantitative variables without normal distribution between two groups. Pearson chi-square, Fisher's exact test, and Fisher-Freeman-Halton exact test were used in comparisons of qualitative data. Statistical significance was accepted as p<0.05 (Karagöz, 2014).

Ethical considerations Ethics committee approval was obtained from the Clinical Research Ethics Committee (Date: December 06, 2021 Number: 2021-23-14) of a training and research hospital (Bakirkoy Dr Sadi Konuk Training and Research Hospital). Institutional permission and permission to use the scale were obtained from the institution where the research would be conducted. Written informed consent was obtained from the patients included in the study.

Being tested
Patient education
Keywords
Fear of Pain, Pain, Pain Management, Patient Education
Medical subject headings
Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient educationOther

    Also called Patients receiving patient education on pain management

    The education given to the intervention group included preoperative preparation, operating room environment, breathing exercises, cough exercises, etc. to be performed after surgery, non-pharmacological methods related to pain management (cold application, positioning, distraction), and pharmacological methods related to pain management.

Study groups in NCT05887596
Study groupRoleWhat they receive
Control groupNo interventionThe training given to the control group included preoperative preparation, operating theatre environment, breathing exercises, cough exercises, etc. to be performed after surgery. In both groups, temperature, pulse rate, blood pressure, oxygen saturation level, and pain level with a Visual/Visual Analogue Scale were measured on the morning of the operation day, before the operation, every 4 hours for 24 hours after the operation and on the day of discharge. Again, pain fear level was measured with the Fear of Pain Scale-III on the day of discharge in both groups.
Intervention groupExperimentalThe education given to the intervention group included preoperative preparation, operating room environment, breathing exercises, cough exercises, etc. to be performed after surgery, non-pharmacological methods related to pain management (cold application, positioning, distraction), and pharmacological methods related to pain management.
Receives: Other: Patient education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Level

    The primary point of the study was defined was assessed by a Visual/Visual Analogue Scale the effect of patient education on pain level in orthopedics and traumatology patients.

    Measured: 3 months

Secondary outcomes (1)
  1. Fear of Pain

    The second point of the study was defined was assessed by the Fear of Pain Scale-III the effect of patient education on fear of pain in orthopedics and traumatology patients.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start15 Dec 2021
  3. Primary completion15 Mar 2022
  4. Study completion15 Mar 2022

Resources

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
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05887596
Sponsor's protocol ID
2021/541
Status last verified
May 2023
First submitted
10 May 2023
Last updated
2 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Caliskan F, Seller A, Gercek M. The Effect of Patient Education on Pain Level and Fear of Pain in Orthopedic Surgery: A Randomized Controlled Trial. J Perianesth Nurs. 2025 Jun;40(3):612-618. doi: 10.1016/j.jopan.2024.07.015. Epub 2024 Oct 24.

    PubMed 39453348

Questions about this trial

What is this clinical trial studying?

A study testing Patient education in people with Fear of Pain and Pain, run by Trakya 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 3 inclusion and 3 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 2 Jun 2023. 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: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05887596, which also lists 1 linked publication.

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 2 Jun 2023.

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