Effectiveness of Guided Imagery Meditation in Patients With Laparoscopic Gallstone Surgery

Gallstone Clinical Trial

Official title:

Effectiveness of Guided Imagery Meditation in Patients With Laparoscopic Gallstone Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390828
• Other study ID #: NYMUH-IRB No. 2019A020
• Status: Completed
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: July 3, 2022

Study information

• Verified date: March 2023
• Source: National Yang Ming Chiao Tung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 3, 2022
• Est. primary completion date: October 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstone
• Gallstones

Intervention

Behavioral:
• Guided Imagery Meditation
the guided image meditation invention program of the intervention measures of this study include four important elements: 1) Meditation exercises: the exercises to adjust the body and mind through specific attention, so that people gradually feel the state of relaxation through practice; (2) Guided image: the simple visualization and use of mental images produced by imagination as a form of psychotherapy, images come from natural scenes (e.g., forests and mountains, streams and oceans), positive feelings and emotions are generated through psychological imagination to induce psychological and physiological relaxation state; (3) Music aids: reaching a relaxed state with comfortable and slow background music; (4) Breathing relaxation training: the patient is taught to take abdominal breathing to divert attention and stimulate the parasympathetic nervous system to achieve muscle relaxation. The entire intervention process takes about 15 to 20 minutes, 2 times a day.

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University Hospital	Ilan
Taiwan	Taiwan: Ministry of Health and Welfare	Ilan

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming Chiao Tung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	11-point Pain Numbered Rating Scale, uses 11 points from 0 to 10 to describe the intensity of pain, 0 point means no pain, points increase as pain increases, 10 points means the most severe pain. Faces pain scale-11, a score of 1-3 points shows mild pain; 4-6 points indicate m moderate pain; 7-10 points indicate severe pain. The higher the pain score, the higher the pain.	up to 12 months
Primary	anxiety	Beck Anxiety Inventory, a total of 21 items describe anxiety symptoms and measure 21 indicators of anxiety. A score of 0-9 points means "normal", 10-18 points indicate "mild" anxiety, 19-29 indicate "moderate" anxiety, and 30-63 points indicate "severe" anxiety.	up to 12 months
Primary	pain control satisfaction	Visual Analogue Scale, this study used Visual Analogue Scale as a scale to assess patient satisfaction with pain control. It is explained to the patient that 0 cm means no pain, 10 cm means very pain, and moving from the left to the right means the pain is higher.	up to 12 months
Primary	sleep quality	Chinese version of Pisttsburgh Sleep Quality Index, is the Chinese version of the Pittsburgh Sleep Quality Each aspect is scored 0-3points, so the total score is 21points. The average score of 5 points is the demarcation point of sleep quality. The higher the score, the worse the sleep quality.	up to 12 months