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

NCT06449144 | Completed

• 1 other identifier: BilecikSeyhEU1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Postoperative Pain; Inguinal Hernia Repair; Mindfulness Training

Keywords

inguinal hernia repair; postoperative pain; mindfulness training; intrusion of pain; fear of pain

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after surgery

Secondary Outcomes (2)

• Fear of Pain

  24 hours after surgery

• Intrusion of pain

  24 hours after surgery

Study Arms (4)

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.

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.

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.

Interventions

Mindfulness education OTHER

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.

mindfulness education with pre-test group; mindfulness education without pre-test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

Study Sites (2)

Bilecik Eğitim ve Araştırma Hastanesi

Bilecik, Turkey (Türkiye)

Location

Bilecik Şeyh Edebali University

Bilecik, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 30312812 BACKGROUND

• Yang 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.

  PMID: 35345623 BACKGROUND

• Hanley 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.

  PMID: 33694345 BACKGROUND

• Dowsey 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.

  PMID: 31519279 BACKGROUND

• Monshat 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.

  PMID: 22621147 BACKGROUND

• McClintock 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.

  PMID: 30523705 BACKGROUND

• Shires 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.

  PMID: 32701830 BACKGROUND

• Bagheri 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.

  PMID: 32709507 BACKGROUND

• Ghielen 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.

  PMID: 31126411 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: February 1, 2024
• Primary Completion: January 15, 2025
• Study Completion: August 15, 2025
• Last Updated: September 19, 2025

Record last verified: 2024-08

Locations

TU (2)