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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449144
• Other study ID #: BilecikSeyhEU1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Bilecik Seyh Edebali Universitesi
• Contact: Hülya Saray Kiliç, RN, PhD.
• Phone: 00902282141793
• Email: hulya.saraykilic[@]bilecik.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia Repair
• Mindfulness Training
• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Turkey	Bilecik Egitim ve Arastirma Hastanesi	Bilecik
Turkey	Bilecik Seyh Edebali University	Bilecik

Sponsors (1)

Lead Sponsor	Collaborator
Bilecik Seyh Edebali Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

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;3 — View Citation

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. Comple — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	24 hours after surgery
Secondary	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.	24 hours after surgery