Postoperative PainNCT06449144
The Effect of Mindfulness Training on Postoperative Pain - A Solomon Four Group Design
A study testing Mindfulness education in people with Postoperative Pain and Inguinal Hernia Repair, run by Bilecik Seyh Edebali Universitesi at 2 sites in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Inguinal Hernia Repair, Mindfulness Training
- What is being tested?
- Mindfulness education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 15 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- agreeing to participate in research
- planned inguinal hernia surgery with mash
- to be able to read and understand Turkish
- ASA I-III
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bilecik Eğitim ve Araştırma Hastanesi
Bilecik
Bilecik Şeyh Edebali University
Bilecik
About this study
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.
Read the 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.
- Being tested
- Mindfulness education
- Keywords
- inguinal hernia repair, postoperative pain, mindfulness training, intrusion of pain, fear of pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness education with pre-test group | Experimental | 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. Receives: Other: Mindfulness education |
| mindfulness education without pre-test group | Experimental | 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. Receives: Other: Mindfulness education |
| control with pre-test group | No intervention | 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. |
| control without pre-test group | No intervention | 24 hours after surgery, surgical information form, fear of pain scale and cognitive intrusion of pain scale will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
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.
Measured: 24 hours after surgery
Secondary outcomes (2)
Fear of Pain
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.
Measured: 24 hours after surgery
Intrusion of pain
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.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Feb 2024
- Primary completion15 Jan 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who are decided to undergo surgery and meet the inclusion criteria will be informed about the study and invited to participate. Patients who agree to participate in the study will be randomly divided into groups. Block randomization will be applied because the participants will receive preoperative and postoperative care in the same clinic and are likely to interact with each other. Awareness training will be given face-to-face by the investigators 24 hours before surgery.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Saray Kılıç, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449144
- Sponsor's protocol ID
- BilecikSeyhEU1
- Status last verified
- Aug 2024
- First submitted
- 3 Jun 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision will be made after consultation with other researchers.
Publications
Yi JL, Porucznik CA, Gren LH, Guan J, Joyce E, Brodke DS, Dailey AT, Mahan MA, Hood RS, Lawrence BD, Spiker WR, Spina NT, Bisson EF. The Impact of Preoperative Mindfulness-Based Stress Reduction on Postoperative Patient-Reported Pain, Disability, Quality of Life, and Prescription Opioid Use in Lumbar Spine Degenerative Disease: A Pilot Study. World Neurosurg. 2019 Jan;121:e786-e791. doi: 10.1016/j.wneu.2018.09.223. Epub 2018 Oct 9.
PubMed 30312812Yang J, Lo WLA, Zheng F, Cheng X, Yu Q, Wang C. Evaluation of Cognitive Behavioral Therapy on Improving Pain, Fear Avoidance, and Self-Efficacy in Patients with Chronic Low Back Pain: A Systematic Review and Meta-Analysis. Pain Res Manag. 2022 Mar 19;2022:4276175. doi: 10.1155/2022/4276175. eCollection 2022.
PubMed 35345623Hanley AW, Garland EL, Zingg RW. Mindfulness-based waiting room intervention for osteopathic manipulation patients: a pilot randomized controlled trial. J Osteopath Med. 2021 Feb 24;121(4):337-348. doi: 10.1515/jom-2020-0186.
PubMed 33694345Dowsey M, Castle D, Knowles S, Monshat K, Salzberg M, Nelson E, Dunin A, Dunin J, Spelman T, Choong P. The effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: A randomised controlled trial. Complement Ther Med. 2019 Oct;46:195-201. doi: 10.1016/j.ctim.2019.08.010. Epub 2019 Aug 12.
PubMed 31519279Monshat K, Castle DJ. Mindfulness training: an adjunctive role in the management of chronic illness? Med J Aust. 2012 May 21;196(9):569-71. doi: 10.5694/mja11.10974.
PubMed 22621147McClintock AS, McCarrick SM, Garland EL, Zeidan F, Zgierska AE. Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. J Altern Complement Med. 2019 Mar;25(3):265-278. doi: 10.1089/acm.2018.0351. Epub 2018 Dec 5.
PubMed 30523705Shires A, Sharpe L, Davies JN, Newton-John TRO. The efficacy of mindfulness-based interventions in acute pain: a systematic review and meta-analysis. Pain. 2020 Aug;161(8):1698-1707. doi: 10.1097/j.pain.0000000000001877.
PubMed 32701830Bagheri H, Salmani T, Nourian J, Mirrezaie SM, Abbasi A, Mardani A, Vlaisavljevic Z. The Effects of Inhalation Aromatherapy Using Lavender Essential Oil on Postoperative Pain of Inguinal Hernia: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Dec;35(6):642-648. doi: 10.1016/j.jopan.2020.03.003. Epub 2020 Jul 21.
PubMed 32709507Ghielen I, Rutten S, Boeschoten RE, Houniet-de Gier M, van Wegen EEH, van den Heuvel OA, Cuijpers P. The effects of cognitive behavioral and mindfulness-based therapies on psychological distress in patients with multiple sclerosis, Parkinson's disease and Huntington's disease: Two meta-analyses. J Psychosom Res. 2019 Jul;122:43-51. doi: 10.1016/j.jpsychores.2019.05.001. Epub 2019 May 13.
PubMed 31126411Saray Kilic H, Ibrahimoglu O, Mercan N, Guneri G. The effect of mindfulness-based preoperative education on postoperative pain: a Solomon four-group randomized controlled trial. BMC Psychol. 2026 Jan 28;14(1):256. doi: 10.1186/s40359-026-04056-w.
PubMed 41606756
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Training on Postoperative Pain - A Solomon Four Group Design
- ClinicalTrials.gov ID
- NCT06449144
- Acronym / sponsor ID
- BilecikSeyhEU1
- Keywords
- inguinal hernia repair, postoperative pain, mindfulness training, intrusion of pain, fear of pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 7 Jun 2024 (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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients who are decided to undergo surgery and meet the inclusion criteria will be informed about the study and invited to participate. Patients who agree to participate in the study will be randomly divided into groups. Block randomization will be applied because the participants will receive preoperative and postoperative care in the same clinic and are likely to interact with each other. Awareness training will be given face-to-face by the investigators 24 hours before surgery.
| Arm | Type | Receives |
|---|---|---|
| mindfulness education with pre-test group | Experimental | Other: Mindfulness education24 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. |
| mindfulness education without pre-test group | Experimental | Other: Mindfulness education24 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. |
| control with pre-test group | No intervention | –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. |
| control without pre-test group | No intervention | –24 hours after surgery, surgical information form, fear of pain scale and cognitive intrusion of pain scale will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- agreeing to participate in research
- planned inguinal hernia surgery with mash
- to be able to read and understand Turkish
- ASA I-III
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Mindfulness educationThe 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. | Other | mindfulness education with pre-test group, mindfulness education without pre-test group |
Primary outcome
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.
2 secondary outcomes
Fear of Pain
Time frame: 24 hours after surgery
Intrusion of pain
Time frame: 24 hours after surgery
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 19 Sep 2025.
- Results publication: PubMed 30312812Yi JL, Porucznik CA, Gren LH, Guan J, Joyce E, Brodke DS, Dailey AT, Mahan MA, Hood RS, Lawrence BD, Spiker WR, Spina NT, Bisson EF. The Impact of Preoperative Mindfulness-Based Stress Reduction on Postoperative Patient-Reported Pain, Disability, Quality of Life, and Prescription Opioid Use in Lumbar Spine Degenerative Disease: A Pilot Study. World Neurosurg. 2019 Jan;121:e786-e791. doi: 10.1016/j.wneu.2018.09.223. Epub 2018 Oct 9.
- Results publication: PubMed 35345623Yang J, Lo WLA, Zheng F, Cheng X, Yu Q, Wang C. Evaluation of Cognitive Behavioral Therapy on Improving Pain, Fear Avoidance, and Self-Efficacy in Patients with Chronic Low Back Pain: A Systematic Review and Meta-Analysis. Pain Res Manag. 2022 Mar 19;2022:4276175. doi: 10.1155/2022/4276175. eCollection 2022.
- Results publication: PubMed 33694345Hanley AW, Garland EL, Zingg RW. Mindfulness-based waiting room intervention for osteopathic manipulation patients: a pilot randomized controlled trial. J Osteopath Med. 2021 Feb 24;121(4):337-348. doi: 10.1515/jom-2020-0186.
- Results publication: PubMed 31519279Dowsey M, Castle D, Knowles S, Monshat K, Salzberg M, Nelson E, Dunin A, Dunin J, Spelman T, Choong P. The effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: A randomised controlled trial. Complement Ther Med. 2019 Oct;46:195-201. doi: 10.1016/j.ctim.2019.08.010. Epub 2019 Aug 12.
- Results publication: PubMed 22621147Monshat K, Castle DJ. Mindfulness training: an adjunctive role in the management of chronic illness? Med J Aust. 2012 May 21;196(9):569-71. doi: 10.5694/mja11.10974.
- Results publication: PubMed 30523705McClintock AS, McCarrick SM, Garland EL, Zeidan F, Zgierska AE. Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. J Altern Complement Med. 2019 Mar;25(3):265-278. doi: 10.1089/acm.2018.0351. Epub 2018 Dec 5.
- Results publication: PubMed 32701830Shires A, Sharpe L, Davies JN, Newton-John TRO. The efficacy of mindfulness-based interventions in acute pain: a systematic review and meta-analysis. Pain. 2020 Aug;161(8):1698-1707. doi: 10.1097/j.pain.0000000000001877.
- Results publication: PubMed 32709507Bagheri H, Salmani T, Nourian J, Mirrezaie SM, Abbasi A, Mardani A, Vlaisavljevic Z. The Effects of Inhalation Aromatherapy Using Lavender Essential Oil on Postoperative Pain of Inguinal Hernia: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Dec;35(6):642-648. doi: 10.1016/j.jopan.2020.03.003. Epub 2020 Jul 21.
- Results publication: PubMed 31126411Ghielen I, Rutten S, Boeschoten RE, Houniet-de Gier M, van Wegen EEH, van den Heuvel OA, Cuijpers P. The effects of cognitive behavioral and mindfulness-based therapies on psychological distress in patients with multiple sclerosis, Parkinson's disease and Huntington's disease: Two meta-analyses. J Psychosom Res. 2019 Jul;122:43-51. doi: 10.1016/j.jpsychores.2019.05.001. Epub 2019 May 13.
- Derived from this study: PubMed 41606756Saray Kilic H, Ibrahimoglu O, Mercan N, Guneri G. The effect of mindfulness-based preoperative education on postoperative pain: a Solomon four-group randomized controlled trial. BMC Psychol. 2026 Jan 28;14(1):256. doi: 10.1186/s40359-026-04056-w.
- Individual participant dataSharing planned: Undecided. A decision will be made after consultation with other researchers.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness education in people with Postoperative Pain and Inguinal Hernia Repair, run by Bilecik Seyh Edebali Universitesi at 2 sites 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 4 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: 24 hours after surgery). 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 NCT06449144, which also lists 10 linked publications.
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 19 Sep 2025.