The Effect of Mindfulness Training on Postoperative Pain - A Solomon Four Group Design

September 16, 2025 updated by: Hülya Saray Kılıç, Bilecik Seyh Edebali Universitesi

The goal of this clinical trial is to learn if mindfulness education works to reduce pain after inguinal hernia operation in adults. The main questions it aims to answer are:

Does mindfulness education reduce the pain level after inguinal hernia operation? Does mindfulness education reduce the pain intrusion level after inguinal hernia operation? Does mindfulness education reduce the fear of pain level after inguinal hernia operation?

Participants will:

Pain level, pain intrusion and fear of pain levels will be determined 24 hours before surgery.

Awareness training will be given before surgery. Pain level, pain intrusion and fear of pain levels will be determined 24 hours after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cognitive behavioral therapy and mindfulness-based therapies are successful practices in reducing anxiety and psychological distress (Ghielen et al. 2019). Mindfulness training includes teaching a range of meditation techniques as well as how to focus on the present moment in daily activities (Monshat, K., & Castle, D. J., 2012). Mindfulness training given to patients undergoing hip replacement surgery has been shown to reduce postoperative pain and improve their physical functioning (Dowsey et al., 2019). Similarly, it has been reported that mindfulness training given to patients who will undergo knee and hip replacement before surgery can prevent postoperative pain and opioid use (Hanley et al., 2021). In a study, mindfulness training used in the management of pain after lumbar disc herniation surgery was found to be useful in managing postoperative pain (Juneyoung et al., 2019). Aromatherapy with lavender oil was found to be effective in reducing pain after inguinal hernia surgery (Bagheri et al., 2020). This suggests that in addition to pharmacological pain management, non-pharmacological methods are also effective in pain management and can be used. In a meta-analysis evaluating the effectiveness of mindfulness-based interventions in acute pain, it was found that there was a lack of good quality evidence for the effectiveness of mindfulness-based interventions in reducing pain severity in clinical or experimental settings (Shires et al., 2020). It is stated that more rigorous large-scale studies conducted with pain populations are needed before cognitive behavioral therapies can be definitively recommended as first-line treatment for acute or chronic pain (McClintock et al., 2021). Therefore, our study was planned to determine the effect of preoperative awareness training on postoperative pain in patients undergoing inguinal hernia repair surgery.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Bilecik, Turkey (Türkiye)
        • Bilecik Eğitim ve Araştırma Hastanesi
      • Bilecik, Turkey (Türkiye)
        • Bilecik Seyh Edebali University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • agreeing to participate in research
  • planned inguinal hernia surgery with mash
  • to be able to read and understand Turkish
  • ASA I-III

Exclusion Criteria:

  • bilateral or revision inguinal hernia surgery planned
  • having a mental illness
  • use of opioid-derived medication in the last month
  • wanting to leave at any stage of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mindfulness education with pre-test group
24 hours before surgery, patients will be administered the sociodemographic information form, the fear of pain scale and the cognitive intrusion of pain scale. Subsequently, awareness training will be given to the patients. 24 hours after surgery, surgical information form, fear of pain scale and cognitive intrusion of pain scale will be administered.
Other: Mindfulness education
The mindfulness-based stress reduction method was examined and a two-step mindfulness education is planned. To reveal the experience of pain: It was planned to conduct interviews with the participants to realize what they think about the pain they have experienced before or what they think about the pain they have experienced here and now, what emotions they have, and their experiences related to their coping processes with pain. Participants will be encouraged to notice negative thoughts that could impact their coping with pain negatively, and they will be provided with education on the benefits of managing the process of changing these negative thoughts. Attempts will be made to establish positive thinking. Attention: Recognizing the relationship between pain sensation and attention and encouraging its expression is included in the intervention. Information on distraction was given and two exercises we planned to increase the level of awareness.
Experimental: mindfulness education without pre-test group
24 hours before surgery awareness training will be given to the patients. 24 hours after surgery, surgical information form, fear of pain scale and cognitive intrusion of pain scale will be administered.
Other: Mindfulness education
The mindfulness-based stress reduction method was examined and a two-step mindfulness education is planned. To reveal the experience of pain: It was planned to conduct interviews with the participants to realize what they think about the pain they have experienced before or what they think about the pain they have experienced here and now, what emotions they have, and their experiences related to their coping processes with pain. Participants will be encouraged to notice negative thoughts that could impact their coping with pain negatively, and they will be provided with education on the benefits of managing the process of changing these negative thoughts. Attempts will be made to establish positive thinking. Attention: Recognizing the relationship between pain sensation and attention and encouraging its expression is included in the intervention. Information on distraction was given and two exercises we planned to increase the level of awareness.
No Intervention: control with pre-test group
24 hours before surgery, patients will be administered the sociodemographic information form, the fear of pain scale and the cognitive intrusion of pain scale. 24 hours after surgery, surgical information form, fear of pain scale and cognitive intrusion of pain scale will be administered.
No Intervention: control without pre-test group
24 hours after surgery, surgical information form, fear of pain scale and cognitive intrusion of pain scale will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: 24 hours after surgery
The Visual Analogue Scale (VAS) of the patients who took the mindfulness education is decreased compared to those who do not. A score between 0 and 10 is taken from the VAS. It is good that the score from the VAS has decreased.
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of Pain
Time Frame: 24 hours after surgery
Fear of pain of the patients who took the mindfulness education is decreased compared to those who do not. A score between 1 and 5 is taken from the scale. It is good that the score from the scale score has decreased.
24 hours after surgery
Intrusion of pain
Time Frame: 24 hours after surgery
Intrusion of pain of the patients who took the mindfulness education is decreased compared to those who do not. A score between 0 and 6 is taken from the scale. It is good that the score from the scale has decreased.
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bilecik Seyh Edebali Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

January 15, 2025

Study Completion (Actual)

August 15, 2025

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BilecikSeyhEU1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A decision will be made after consultation with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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