Effectiveness of Guided Imagery Meditation in Patients With Laparoscopic Gallstone Surgery

NCT04390828 | Completed

• 1 other identifier: NYMUH-IRB No. 2019A020
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Gallstone

Keywords

Guided imagery meditation, Gallstones

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Guided Imagery Meditation

EXPERIMENTAL

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.

Behavioral: Guided Imagery Meditation

Usual care

NO INTERVENTION

usual care

Interventions

Guided Imagery Meditation BEHAVIORAL

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.

Guided Imagery Meditation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University Hospital: lead

Study Sites (2)

National Yang-Ming University Hospital

Yilan, Taiwan

Location

Taiwan: Ministry of Health and Welfare

Yilan, Taiwan

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi-Ju Lu

  National Yang-Ming Unerversity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: May 18, 2020
• Study Start: October 25, 2019
• Primary Completion: October 25, 2020
• Study Completion: July 3, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)