Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315796
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2006-04-17
Brief Title:
Nature Sights and Sounds to Reduce Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Nature Sights and Sounds to Reduce Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pain is a common and difficult problem for patients with cancer It has been reported that over 80 of cancer patients suffer from pain Much of this pain is iatrogenic and related to procedures Dr Grossman recently demonstrated that most patients undergoing bone marrow biopsy have poor pain control during the procedure Treatment of pain is almost entirely with analgesic medications principally opioids These medications have numerous undesirable effects such as sedation confusion hypotension and constipation that limit their efficacy and utility Drs Diette Lechtzin Rubin and colleagues recently demonstrated that use of nature sights and sounds NSS a simple safe and inexpensive intervention decreases pain during fiberoptic bronchoscopy a procedure commonly performed to diagnose cancer and to detect pulmonary complications of cancer therapy Patients were randomly assigned to either standard care with intravenous narcotics and benzodiazepines or standard care coupled with view of a nature scene and use of nature sounds before during and after bronchoscopy The group assigned to the NSS reported significantly better pain control than the control group While these findings are novel and exciting they raised several new questions that suggest logical extensions of this work It is not known whether this intervention can be applied to patients in other settings nor is it known whether comparison to standard care is an appropriate control group Further the mechanism of action of NSS needs to be determined NSS may simply be a form of distraction therapy but it may have other properties The theory of biophilia proposes there are specific elements in nature imagery that exert beneficial health effects Because NSS appears to be a promising and safe intervention for the treatment of pain these investigators plan to perform a controlled clinical trial in cancer patients undergoing invasive procedures Patients will be randomly assigned to one of three arms standard care NSS and a non-nature based distraction technique We will study the efficacy of NSS for the management of procedure-related pain in oncology patients The findings will provide necessary background information to develop more definitive studies of NSS that should be competitive for external funding This exciting study will help develop a harmless inexpensive method to treat pain in cancer patients that may complement or replace analgesic medications
Detailed Description:
Study Design This is a randomized controlled trial assessing the impact of nature sights and sounds NSS on pain control in oncology outpatients undergoing bone marrow aspirate and biopsy BMBx in the Weinberg Cancer Center at Johns Hopkins One hundred twenty patients will be assigned to one of three groups 1 standard care 2 NSS 3 MusicPhoto The primary outcome will be pain scores during the procedures as measured by the Hopkins Pain Rating Instrument HPRI Patients in all groups will receive analgesic medications as dictated by the personnel performing the procedure and the physicians responsible for their clinical care Patients in the NSS group will have Bedscapes nature scene murals placed at the bedside in a location that is visible throughout the procedure They will also listen to a complementary audiotape during the procedure The musicphoto group will listen to city sounds during the procedure and view a poster of a city skyline
Setting The study will be conducted in the Weinberg Cancer Pavilion of the Kimmel Cancer Center at the Johns Hopkins Hospital
Patient Selection All patients 18 years and older with a diagnosis of cancer undergoing a BMBx in the Johns Hopkins Oncology Center will be screened for enrollment in the study
Informed Consent The study design and consent procedure will be explained to all prospective patients If patients are interested in taking part in the study written informed consent will be obtained The study nurse will administer a mental status exam and assess eligibility Consent and screening must occur within 5 days of the patients procedure
Randomization Blocked randomization will be used with variable block sizes to ensure roughly equal numbers of patients in each study arm
Study Interventions All subjects will have pain managed by the physicians responsible for their clinical care as dictated by those physicians Subjects assigned to NSS will have Bedscapes fabric panels depicting a scene of a mountain stream placed by the procedure table at a location where it will be visible throughout the procedure An accompanying audiotape of complementary nature sounds will be played on portable tape players through headphones or speakers They will be instructed to listen to the tape and look at the nature scene as frequently and for as long as they desire The standard care group will have pain managed according to current oncology center protocols but will not be allowed to use the distraction interventions The MusicPhoto group will be played a tape of typical city sounds and will have a poster of a city skyline placed by the procedure table The city skyline poster will be similar in size to the Bedscapes mural The skyline image is a daytime photograph without water trees or other nature elements The subjects will be asked to listen to the music and view the picture during the procedure
The HPRI will be used to measure pain This is a plastic VAS with a sliding marker that moves within a grove The side facing the patient appears like a traditional VAS It has a 10cm line with the anchors No Pain and Worst Pain Imaginable The opposite side of the instrument is a 10 cm scale with markings every 05cm that enables the clinician to read and record numerical values see figure in appendix Scores will be recorded to the nearest 05cm All patients will have a baseline assessment of pain immediately prior to the procedure Subjects will be interviewed within one hour following the procedure and will be asked to quantify their pain during the procedurePatients will also complete a questionnaire following the procedure in which they will score their level of pain control during the procedure on a 5-point Likert scale which was used in the bronchoscopy study
Data Collection Following the procedure patients will complete a set of questionnaires Questions will inquire about attitudes beliefs and prior use of CAM Patients in the NSS and MusicPhoto groups will be asked whether they found the study intervention to be helpful and if so what aspects of the intervention were beneficial They will be asked to rate their satisfaction with several aspects of the procedure including comfort the nursing care the physician care and the facility Psychological distress will be measured with the Brief Symptom Index 18 negative mood states and anxiety will be measured with the Profile of Mood States POMS The BSI provides a global symptom severity score that will be used to control for subjects underlying psychological distress while POMS is well suited to measuring changes in mood related to the procedure We will specifically focus on the Tension-Anxiety Depression-Dejection Anger-Hostility and Confusion-Bewilderment subscales Differences in response to pain will be measured with the Pain Catastrophizing Scale Salivary cortisol will be measured before and after the procedure as a neuroendocrine marker of stress Two baseline measurements of cortisol will be taken at least 15 minutes apart prior to the procedure Immediately following the procedure three additional salivary cortisol samples will be collected approximately 15 minutes apart The study nurse will record heart rate blood pressure and respiratory rate before and every 15 minutes during the procedures The high and low systolic blood pressure heart rate and respiratory rate will be extracted The study nurse will record the percentage of time the patient used the study intervention during the procedure Patients will also be asked what percentage of the time they used the intervention
Outcomes The primary outcomes is to determine if NSS is effective at reducing pain in cancer patients undergoing invasive procedures we will compare mean pain scores during the procedure from the HPRI between the NSS group and the standard care group We will also compare the difference between ratings of baseline pain and pain during the procedure in the two groups and the rating of pain control during the procedure between the groups We will also determine if NSS reduces pain more than non-nature based distraction therapy we will compare pain ratings and the difference in pain ratings from baseline to that during the procedure between the NSS and the musicphoto group Lastly we will determine if NSS reduces affective distress in cancer patients undergoing painful procedures we will compare mean scores from the POMS between the three groups Secondary outcomes that pertain to all specific aims include vital signs during procedures and salivary cortisol levels We will also assess overall satisfaction with care ratings of physicians ratings of nurses and attitudes towards CAM interventions using Likert-type scales
Sample Size The primary outcome is difference in maximal pain level during procedures between the NSS group and the MusicPhoto group Power estimates are based on the magnitude of effect from the bronchoscopy study and the standard deviation of pain ratings in bone marrow biopsies studied by Dr Grossman In order to have 80 power to detect a 2-point difference in pain rating using the HPRI with an alpha error level of 005 we will need 29 patients in each group total n87 We plan to enroll 40 patients in each group total n120 to compensate for study withdrawal and missing data We will continue to enroll patients until we have met these goals
Data Entry and Management The Biostatistics Core of the CAM center will provide recommendations on data entry and analysis Because this is a small single center trial of a relatively safe intervention there will not be a formal data safety monitoring committee However Dr Lechtzin will oversee data integrity
Adverse Events Monitoring This is a minimal risk intervention and we expect very few adverse events During our bronchoscopy study there was only one adverse event a patient became incontinent on the procedure table due to the sound of running water Adverse events to the experimental intervention will be assessed at the interview following the procedure by recording all voluntary complaints of subjects and through structured interviews Attention will be directed to clinical adverse experiences associated with the procedure and the experimental intervention In addition all study participants will be provided a telephone number they can contact 24 hoursday 7 daysweek in case of questions concerns or adverse events Adverse events will be documented on a standardized case report form Summary reports of adverse events will be generated every three months Dr Lechtzin will review these All serious adverse events including death hospitalization and premature withdrawal will be reported to the principal investigator within 24 hours of their occurrence The principal investigator will report all serious adverse events to the Johns Hopkins IRB Unexpected adverse events will be reported within 10 days
Statistical Analysis Analyses will be based on intention to treat Analyses will be performed comparing patients who used NSS to the standard care group and the MusicPhoto group Descriptive analyses will be performed to assess subject characteristics demographics disease characteristics education prior CAM use and attitudes Procedure characteristics will be compared including duration complications and medication usage Continuous variables will be represented as mean plus or minus SE medians and interquartile ranges Bivariate analyses of outcomes will compare pain ratings POMS subscales and psychological distress between the groups Chi squared test or Fishers Exact test will be used to compare categorical variables such as age gender and race between groups Unpaired t-tests or the Kruskal Wallis test will be used to compare continuous outcomes such as Pain Inventory scores Pain scores will be analyzed as continuous variables and will also be categorized into mild 0-2 moderate 3-6 and severe 7-10 Multivariate analyses will be performed in order to adjust for possible confounding factors such as amount of narcotic analgesics given and amount of local anesthetic used Ordinal logistic regression models to explain pain level by study intervention will be developed to adjust for factors such as age gender race procedure type education level local anesthetic dose narcotic dose benzodiazepine dose and BSI score Additional factors will be included in the models if they are significant in bivariate analyses Logistic regression models will be developed to determine factors associated with favorable response to NSS Stepwise maximum-likelihood ratio estimation with a significance level of 02 for removal and 01 for inclusion will assist in model development For all analyses significance will be set at p005
Setting The study will be conducted in the Weinberg Cancer Pavilion of the Kimmel Cancer Center at the Johns Hopkins Hospital
Patient Selection All patients 18 years and older with a diagnosis of cancer undergoing a BMBx in the Johns Hopkins Oncology Center will be screened for enrollment in the study
Informed Consent The study design and consent procedure will be explained to all prospective patients If patients are interested in taking part in the study written informed consent will be obtained The study nurse will administer a mental status exam and assess eligibility Consent and screening must occur within 5 days of the patients procedure
Randomization Blocked randomization will be used with variable block sizes to ensure roughly equal numbers of patients in each study arm
Study Interventions All subjects will have pain managed by the physicians responsible for their clinical care as dictated by those physicians Subjects assigned to NSS will have Bedscapes fabric panels depicting a scene of a mountain stream placed by the procedure table at a location where it will be visible throughout the procedure An accompanying audiotape of complementary nature sounds will be played on portable tape players through headphones or speakers They will be instructed to listen to the tape and look at the nature scene as frequently and for as long as they desire The standard care group will have pain managed according to current oncology center protocols but will not be allowed to use the distraction interventions The MusicPhoto group will be played a tape of typical city sounds and will have a poster of a city skyline placed by the procedure table The city skyline poster will be similar in size to the Bedscapes mural The skyline image is a daytime photograph without water trees or other nature elements The subjects will be asked to listen to the music and view the picture during the procedure
The HPRI will be used to measure pain This is a plastic VAS with a sliding marker that moves within a grove The side facing the patient appears like a traditional VAS It has a 10cm line with the anchors No Pain and Worst Pain Imaginable The opposite side of the instrument is a 10 cm scale with markings every 05cm that enables the clinician to read and record numerical values see figure in appendix Scores will be recorded to the nearest 05cm All patients will have a baseline assessment of pain immediately prior to the procedure Subjects will be interviewed within one hour following the procedure and will be asked to quantify their pain during the procedurePatients will also complete a questionnaire following the procedure in which they will score their level of pain control during the procedure on a 5-point Likert scale which was used in the bronchoscopy study
Data Collection Following the procedure patients will complete a set of questionnaires Questions will inquire about attitudes beliefs and prior use of CAM Patients in the NSS and MusicPhoto groups will be asked whether they found the study intervention to be helpful and if so what aspects of the intervention were beneficial They will be asked to rate their satisfaction with several aspects of the procedure including comfort the nursing care the physician care and the facility Psychological distress will be measured with the Brief Symptom Index 18 negative mood states and anxiety will be measured with the Profile of Mood States POMS The BSI provides a global symptom severity score that will be used to control for subjects underlying psychological distress while POMS is well suited to measuring changes in mood related to the procedure We will specifically focus on the Tension-Anxiety Depression-Dejection Anger-Hostility and Confusion-Bewilderment subscales Differences in response to pain will be measured with the Pain Catastrophizing Scale Salivary cortisol will be measured before and after the procedure as a neuroendocrine marker of stress Two baseline measurements of cortisol will be taken at least 15 minutes apart prior to the procedure Immediately following the procedure three additional salivary cortisol samples will be collected approximately 15 minutes apart The study nurse will record heart rate blood pressure and respiratory rate before and every 15 minutes during the procedures The high and low systolic blood pressure heart rate and respiratory rate will be extracted The study nurse will record the percentage of time the patient used the study intervention during the procedure Patients will also be asked what percentage of the time they used the intervention
Outcomes The primary outcomes is to determine if NSS is effective at reducing pain in cancer patients undergoing invasive procedures we will compare mean pain scores during the procedure from the HPRI between the NSS group and the standard care group We will also compare the difference between ratings of baseline pain and pain during the procedure in the two groups and the rating of pain control during the procedure between the groups We will also determine if NSS reduces pain more than non-nature based distraction therapy we will compare pain ratings and the difference in pain ratings from baseline to that during the procedure between the NSS and the musicphoto group Lastly we will determine if NSS reduces affective distress in cancer patients undergoing painful procedures we will compare mean scores from the POMS between the three groups Secondary outcomes that pertain to all specific aims include vital signs during procedures and salivary cortisol levels We will also assess overall satisfaction with care ratings of physicians ratings of nurses and attitudes towards CAM interventions using Likert-type scales
Sample Size The primary outcome is difference in maximal pain level during procedures between the NSS group and the MusicPhoto group Power estimates are based on the magnitude of effect from the bronchoscopy study and the standard deviation of pain ratings in bone marrow biopsies studied by Dr Grossman In order to have 80 power to detect a 2-point difference in pain rating using the HPRI with an alpha error level of 005 we will need 29 patients in each group total n87 We plan to enroll 40 patients in each group total n120 to compensate for study withdrawal and missing data We will continue to enroll patients until we have met these goals
Data Entry and Management The Biostatistics Core of the CAM center will provide recommendations on data entry and analysis Because this is a small single center trial of a relatively safe intervention there will not be a formal data safety monitoring committee However Dr Lechtzin will oversee data integrity
Adverse Events Monitoring This is a minimal risk intervention and we expect very few adverse events During our bronchoscopy study there was only one adverse event a patient became incontinent on the procedure table due to the sound of running water Adverse events to the experimental intervention will be assessed at the interview following the procedure by recording all voluntary complaints of subjects and through structured interviews Attention will be directed to clinical adverse experiences associated with the procedure and the experimental intervention In addition all study participants will be provided a telephone number they can contact 24 hoursday 7 daysweek in case of questions concerns or adverse events Adverse events will be documented on a standardized case report form Summary reports of adverse events will be generated every three months Dr Lechtzin will review these All serious adverse events including death hospitalization and premature withdrawal will be reported to the principal investigator within 24 hours of their occurrence The principal investigator will report all serious adverse events to the Johns Hopkins IRB Unexpected adverse events will be reported within 10 days
Statistical Analysis Analyses will be based on intention to treat Analyses will be performed comparing patients who used NSS to the standard care group and the MusicPhoto group Descriptive analyses will be performed to assess subject characteristics demographics disease characteristics education prior CAM use and attitudes Procedure characteristics will be compared including duration complications and medication usage Continuous variables will be represented as mean plus or minus SE medians and interquartile ranges Bivariate analyses of outcomes will compare pain ratings POMS subscales and psychological distress between the groups Chi squared test or Fishers Exact test will be used to compare categorical variables such as age gender and race between groups Unpaired t-tests or the Kruskal Wallis test will be used to compare continuous outcomes such as Pain Inventory scores Pain scores will be analyzed as continuous variables and will also be categorized into mild 0-2 moderate 3-6 and severe 7-10 Multivariate analyses will be performed in order to adjust for possible confounding factors such as amount of narcotic analgesics given and amount of local anesthetic used Ordinal logistic regression models to explain pain level by study intervention will be developed to adjust for factors such as age gender race procedure type education level local anesthetic dose narcotic dose benzodiazepine dose and BSI score Additional factors will be included in the models if they are significant in bivariate analyses Logistic regression models will be developed to determine factors associated with favorable response to NSS Stepwise maximum-likelihood ratio estimation with a significance level of 02 for removal and 01 for inclusion will assist in model development For all analyses significance will be set at p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCCAM AT00437 | None | None | None |