Clinical trial: NCT05690230
Section: Alternatives
Subsections: 76 Alternatives To Taking Part In This Research

77 78 The alternative to being in this study is to not take part.  
79 80 **Payment**
81 PI:  
Abbreviated Title: Improving Patient Experience: BMBA
82 You will not be paid for taking part in this study. If this research or the information or specimens 83 you provide result in commercial profit, you will not receive any money from that profit.  
84
Clinical trial: NCT05690230
Section: Confidentiality
Subsections: 169 Privacy And Confidentiality: Hipaa Authorization

170 171 Information will be collected about you for this study. The information will be seen by the people 172 involved with this research. Steps will be taken to protect your identity. But the information 173 collected about you can never be 100% secure.  
174 175 HIPAA (Health Insurance Portability and Accountability Act) - This is the law that protects your 176 personal health information.  
177 178 To do this study, we need to collect, use, and share your personal health information. This form 179 will explain why your information is being collected, what information will be collected, and who 180 will have access to it. By signing, you are giving us permission to use your information as described 181 in this form.  
182 183 We are committed to respecting your privacy and to keeping your personal health information 184 confidential. Your personal health information includes the information in your health care 185 records and information that can identify you. For example, personal information may include 186 your name, address, phone number, social security number, and medical information. The 187 personal health information that may be collected, used, and shared for this research includes:
188 189  Information from your medical records 190  Demographic information such as name, gender, birth date, ethnicity, medical history, 191 health care providers, race, and ethnicity 192  Physical examinations, procedures, tests, labs, your medical conditions, and medications 193 you use 194  Information collected about any research related injury 195  Information about mental health, sexually transmitted diseases, HIV, AIDS, drug and 196 alcohol use, genetic test results, and other sensitive information 197  Vitals, including heart rate, blood pressure, and respiratory rate 198  Questionnaires about your experience 199 200 Your personal information will be used by and shared with the following:
201 202  Personnel at Thomas Jefferson University and its affiliates for the purpose of this research 203  Institutional Review Boards (ethics committees that review research) including the 204 Jefferson IRB
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Abbreviated Title: Improving Patient Experience: BMBA
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205  Health insurance providers 206  Public health authorities who monitor such things as sexually transmitted diseases, HIV,
207 AIDS, child abuse, as required by law 208  Groups monitoring the safety of the study such as a data and safety monitoring committee 209  Others as required by law 210 211 When your personal information is provided to some of the people listed, it may no longer be 212 protected under the HIPAA privacy law. You can see your health care records at any time.  
213 However, generally you will not be able to see your study records or the study results until the 214 study is completed. A copy of this signed form, information about this study, and the results of 215 any study test or procedure may be included in your health records which may be seen by your 216 insurance company and your health care providers.  
217 218 This authorization does not have an expiration date. Please inform the investigator in writing if 219 you want to end your permission to collect information/samples. Please note that anything 220 already collected will still be used and you may not be able to continue in this study.  
221 222 The information from this study may be published in scientific journals or presented at scientific 223 meetings, but you will not be personally identified.  
224 225 A description of this study will be available on http://www.ClinicalTrials.gov, as required by U.S.  
226 Law. This website will not include information that can identify you. At most, the website will 227 include a summary of the results. You can search this website at any time.  
228 229 Your private information, with the identifiers removed, could be used for future research studies 230 or distributed to other researchers for future research studies without your additional 231 permission.  
232 233 **Contacts**
234 235 If you are having a medical emergency, call 911 or go directly **to an emergency room. You**
236 should let emergency personnel or providers know that you are taking part **in this study.**
237 238 PI:  
Abbreviated Title: Improving Patient Experience: BMBA
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| For Questions About:                                                                                                  | Person or Office                           | Contact Information           |
|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------|
| The Study or Research Related                                                                                         | Main Investigator: Anne                    |                               |
| Injury                                                                                                                | Delengowski Investigator: Michelle  Lasota | (215) 955-7098 (267) 438-6652 |
| If you need to contact someone  other than the study personnel  about a concern or your rights as  a research subject | Jefferson Center City                      | 215-503-0203                  |
| Institutional Review Board  (Ethics Committee)                                                                        | 215-503-8966 215-955-4239                  |                               |  
Version Date: 01/10/2022  
  
  
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Abbreviated Title: Improving Patient Experience: BMBA
241 **Signatures**  
  
242 243 Patient/Subject: By signing this form, you are agreeing that:
244 245  You were given the opportunity to read this form.  
246  All of the information in this form was discussed with you by an investigator or other 247 research personnel to your satisfaction.  
248  All your questions have been answered to your satisfaction.  
249  You were not pressured and you voluntarily agree to take part in this research.  
250 251 252 ______________________ ______________________ __________
253 Your Name Your **Signature** Date 254 255 256 ______________________ ______________________ __________ 257 Name of Person Obtaining/ Signature of Person Obtaining/ Date 258 Assisting with Consent Assisting with Consent 259 260 The investigator's signature certifies that the study participant has been provided with a 261 description of the study, study procedures, risks, benefits and alternatives to participation.  
262 263 264 ______________________ ______________________ __________
265 Name of Investigator Signature of Investigator Date 266 267 268 ______________________ ______________________ __________
269 Name of Witness Signature of Witness Date 270 *(Witness required if the only language the subject speaks and understands is English, but the* 271 *subject cannot read English, or if the subject is blind or cannot physically sign the consent form.)*
272 273 274 275 276 277 278 279 280 281 Copy of Signed and Dated Consent Form Given to the Subject/LAR
Clinical trial: NCT05690230
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 152 Research-Related Injury

153 154 There is a possibility that you could have research-related injury, which is an illness or an injury 155 that is directly caused by the study interventions or a study procedure. If you have a research-156 related injury, we will offer you reasonable and necessary care to treat injuries directly resulting 157 from taking part in this research. Neither Jefferson nor the study will pay for costs associated with 158 treatment of research-related injury or illness. These costs may be billed to your insurance. In 159 addition, you will be responsible for any deductibles and co-payments required under your health 160 plan and for any claims ultimately denied by your health plan. There are no plans for Jefferson to 161 pay you or give you other compensation for the injury. If you think you have been injured as a 162 result of taking part in this research study, tell the research personnel as soon as possible. Please 163 see the contact information in this consent form.  
164 165 **Disclosure of Financial Interest**
166 167 This study has been funded by the DAISY Foundation's J. Patrick Barnes Grant.  
168
Clinical trial: NCT05690230
Section: Procedures
Subsections: 63 Procedures And Risks

64 65 It is important that you know the procedures and risks involved in this research. These will be 66 discussed with you and are included in detail later in this form. Review the information carefully 67 when making your decision to take part in this research.  
68 69 **Possible Benefits**
70 71 You may personally benefit from taking part in this research. Some of the possible benefits may 72 be decreased distress, decreased pain, and improved satisfaction. Your participation will help us 73 understand what methods are best to improve the overall patient experience during this 74 procedure.  
75
Clinical trial: NCT05690230
Section: Purpose of Research
Subsections: 47 How This Research Is Different From Standard Medical Care

48 49 Depending on which group you are assigned to, you may receive different tools to help promote 50 relaxation and reduce distress during your procedure. These include changes to the room 51 environment, music, guided meditation, and virtual reality. These are all techniques that have 52 been used to help reduce pain and distress for cancer patients, but they have not been specifically 53 used during bone marrow biopsies.  
54 55 **Number of Participants**
56 57 About 60 people will take part in this research in the whole study at Jefferson.  
58 59 **Duration**
60 61 You will be in this research study for a single bone marrow biopsy procedure visit.  
62
Clinical trial: NCT05690230
Section: Voluntary Participation
Subsections: 34 Voluntary Participation

35 36 You do not have to take part in this research. It is your choice whether or not you want to take 37 part. If you choose not to take part or choose to stop taking part at any time, there will be no 38 penalty or loss of benefits that you would normally get.  
39 40 **Purpose**
41 Version Date: 01/10/2022 Version Number: 1.1 Page 2 of 8 PI:  
Abbreviated Title: Improving Patient Experience: BMBA
42 The purpose of this research is to explore ways of improving the patient experience during visits 43 for bone marrow biopsies. This procedure can be painful and cause distress. This study will look 44 at alternative ways of promoting relaxation and distraction both while waiting before the 45 procedure and during the procedure.  
46
Clinical trial: NCT05690230
Section: Withdrawal from Study
Subsections: 85 Ending Study Early

86 87 There are a number of reasons you may decide or be asked to stop the study early (example: 88 medical issues). You may also have to stop the study early even if you do not want to. You and 89 the research personnel will discuss the reason if this becomes necessary. If you do leave the 90 study early, you may be asked to complete some of the procedures described in this form. This 91 will include completing the post-procedure survey.  
92 93 **New Information**
94 95 New information may come out during this study. You will be given any new information that 96 could change your decision to take part. You may ask to see the information collected about you, 97 but not until the entire study is complete. You will be given any research results that could affect 98 your health.  
99 100 **Detailed Information Section**
101 102 **Drugs/Devices**
103 104 The two interventions used in this study are described below:
105 106 Intervention 1 uses a virtual reality headset to provide a guided meditation experience. Virtual 107 reality, or VR, is a simulated experience that combines going to a movie with the interactions of 108 playing a computer or video game. It usually involves wearing a headset over the eyes and using 109 a controller or remote to interact with the VR content. The content for this study is a guided 110 meditation application. Guided meditation is a relaxation technique used to provide stress relief 111 and reduce tension. A teacher, video, or audio recording is used to help focus on breathing, 112 pleasant scenery, or music.  
113 114 Intervention 2 will be changes to the procedure room environment. These will include nature 115 imagery and a selection of music. You will be able to choose from a selection of music stations or 116 to pick your favorite type of music to listen to before and during the procedure. Music therapy 117 and nature imagery help provide stress relief and promote relaxation.  
118 119 There is a 50% chance you will be assigned to one of these interventions. There is also a 50%
120 chance you will be assigned to a control group. Control group participants will receive normal 121 standard of care during their procedure and be asked to answer questions about their experience.  
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123 **Procedures**
124 125 While you are in this study, you will have your bone marrow biopsy procedure as part of your 126 normal care. Please note that additional tests and procedures are not expected but may be 127 needed to check on your health condition.  
128 129 Name of Procedure: Bone Marrow Biopsy / Aspiration 130 131 Description: After numbing the procedure area with lidocaine, a small fragment of bone will be 132 removed along with a small sample of marrow using a needle. This will be done one time during 133 your visit.  
134 135 Name of Evaluation: Vital Signs 136 137 Description: Before your bone marrow biopsy procedure, your heart rate, blood pressure, and 138 respiratory rate will be recorded. Each will be taken once before your procedure.  
139 140 **Risks**
141 142 Taking part in this study involves certain risks. There may be different risks depending on what 143 group you are assigned to. There may also be risks that are not known at this time. If you have 144 any medical issues during this study, call the appropriate number in the contacts section of this 145 form.  
146 147 Intervention 1: Virtual reality may cause symptoms associated with motion sickness, including 148 nausea, dizziness, disorientation, and vertigo. Mild eyestrain or headaches may also occur.  
149 150 Intervention 2: There are no known risks associated with music therapy or décor changes.  
151