Clinical trial NCT04390828: Effectiveness of Guided Imagery Meditation in Patients With Laparoscopic Gallstone Surgery
Official title: Effectiveness of Guided Imagery Meditation in Patients With Laparoscopic Gallstone Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallstone
Keywords: Guided imagery meditation, Gallstones
Lead sponsor: National Yang Ming Chiao Tung University Hospital
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Guided image meditation has been shown to alter the functional circuits of the brain to alleviate pain by mediating breathing and thoughts. Therefore, the purpose of this study is to investigate whether the intervention with guided image meditation after laparoscopic cholecystectomy can effectively alleviate postoperative pain, reduce anxiety, promote sleep quality, and increase pain control satisfaction for the patients with gallstones.

Detailed description: Gallstone is the most common digestive tract disease in general surgical wards. The incidence of gallstones in Chinese is about 5-10%, and the patients often seek hospital treatment due to abdominal pain. At present, most gallstones are treated with laparoscopic cholecystectomy, and postoperative pain is one of the most troublesome problems for surgical patients. However, up to 90% of patients undergoing abdominal surgery still experience moderate to severe pain, which not only affects the patient's physical recovery, but also causes psychological anxiety. Therefore, it is important to provide good postoperative pain management. Guided image meditation has been shown to alter the functional circuits of the brain to alleviate pain by mediating breathing and thoughts. Therefore, the purpose of this study is to investigate whether the intervention with guided image meditation after laparoscopic cholecystectomy can effectively alleviate postoperative pain, reduce anxiety, promote sleep quality, and increase pain control satisfaction for the patients with gallstones.

This study used 2×2 pre-test and post-test randomized control tests with randomized, single-blind, experimental study design. The research subjects were recruited from the general surgical ward of the North District Teaching Hospital. The study questionnaire included the assessment of pain levels using the 11-point Numeric Rating Scale (NRS-11) and the 11-face Face Pain Scale (FPS-11), the degree of anxiety using the Chinese version of Beck Anxiety Inventory (BAI), pain control satisfaction using Visual Analogue Scales (VAS), and sleep quality using the Chinese Pittsburgh Sleep Quality Index (CPSQI). The number of samples in this study was calculated by G-Power 3.1.2 statistical software. At least 68 samples were collected and grouped by random allocation, with 34 each for the control group (conventional scheme) and the experimental group (guided image meditation intervention). After the pre-test, the two groups were post-tested on the first postoperative day. The data obtained in this study were statistically analyzed by statistical software SPSS 22.0 for descriptive statistics including number of assignments, percentage, mean, standard deviation, Maximum and Minimum. Inferential statistical analysis by analysis of variance (ANOVA), Chi-square test, independent sample t-test, logistic regression, Pearson's correlation, repeated measures ANOVA and Generalized Estimating Equation (GEE) tested the pre-test and post-test results of the experimental group and the control group to compare the difference between the two groups in pain index, anxiety level, sleep quality and pain control satisfaction.

This study intended to use the characteristics of the guided image meditation being easy to learn and easy to operate and the evidence-based measures to alleviate postoperative pain, reduce anxiety, promote sleep quality and improve post-surgical pain control satisfaction to prove the empirical effect of guided image meditation in clinical care. It is hoped to provide an empirically based interventional effect to improve the problems associated with patients after laparoscopic surgery and improve the quality of life of patients after surgery. The results of this paper are expected to be published in domestic and foreign journals, so as to add to empirical academic literature and to be shared by medical staff for increasing new knowledge.

Eligibility criteria: Inclusion Criteria:

* at least 20 years old, and diagnosed as having gallstones and had laparoscopic cholecystectomy
* conscious, can communicate in Mandarin and Taiwanese; and have agreed to participate in the study.

Exclusion Criteria:

* with hearing or vision severely impaired
* cognitive mental disorder, such as mental illness
* who are unwilling to participate in this study.

Primary outcomes:
measure: pain score
timeFrame: up to 12 months
measure: anxiety
timeFrame: up to 12 months
measure: pain control satisfaction
timeFrame: up to 12 months
measure: sleep quality
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ilan
country: Taiwan
facility: National Yang-Ming University Hospital
city: Ilan
country: Taiwan
facility: Taiwan: Ministry of Health and Welfare
Study officials:
affiliation: National Yang-Ming Unerversity Hospital
name: Yi-Ju Lu
role: PRINCIPAL_INVESTIGATOR
References: