Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06449144
Enrollment
68
Registered
2024-06-07
Start date
2024-02-01
Completion date
2025-08-15
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia Repair, Mindfulness Training, Postoperative Pain

Keywords

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

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.

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.

Interventions

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.

Sponsors

Bilecik Seyh Edebali Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain level24 hours after surgeryThe 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.

Secondary

MeasureTime frameDescription
Fear of Pain24 hours after surgeryFear 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.
Intrusion of pain24 hours after surgeryIntrusion 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026