GallstoneNCT04390828
Effectiveness of Guided Imagery Meditation in Patients With Laparoscopic Gallstone Surgery
A study testing Guided Imagery Meditation in people with Gallstone, run by National Yang Ming Chiao Tung University Hospital at 2 sites in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gallstone
- What is being tested?
- Guided Imagery Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTaiwan
- Study dates
- 25 Oct 2019to 3 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- with hearing or vision severely impaired
- cognitive mental disorder, such as mental illness
- who are unwilling to participate in this study.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Yang-Ming University Hospital
Yilan
Taiwan: Ministry of Health and Welfare
Yilan
About this study
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.
Read the 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.
- Conditions
- Gallstone
- Being tested
- Guided Imagery Meditation
- Keywords
- Guided imagery meditation, Gallstones
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery MeditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Guided Imagery Meditation |
| Usual care | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start25 Oct 2019
- Primary completion25 Oct 2020
- Study completion3 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Ju Lu, National Yang Ming Chiao Tung University Hospital
- Investigators
- Yi-Ju Lu, Principal investigator, National Yang-Ming Unerversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390828
- Sponsor's protocol ID
- NYMUH-IRB No. 2019A020
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2019
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Guided Imagery Meditation in Patients With Laparoscopic Gallstone Surgery
- ClinicalTrials.gov ID
- NCT04390828
- Acronym / sponsor ID
- NYMUH-IRB No. 2019A020
- Conditions
- Gallstone
- Keywords
- Guided imagery meditation, Gallstones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung University HospitalUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 3 Jul 2022 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery Meditation | Experimental | Behavioral: Guided Imagery Meditationthe 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. |
| Usual care | No intervention | –usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- with hearing or vision severely impaired
- cognitive mental disorder, such as mental illness
- who are unwilling to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Imagery Meditationthe 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. | Behavioural | Guided Imagery Meditation |
Primary outcome
pain score
Time frame: up to 12 months
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.
anxiety
Time frame: up to 12 months
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.
pain control satisfaction
Time frame: up to 12 months
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.
sleep quality
Time frame: up to 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Gallstone
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Ju Lu principal investigator
National Yang-Ming Unerversity Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery Meditation in people with Gallstone, run by National Yang Ming Chiao Tung University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.