Tyc 1997.
Study characteristics | ||
Methods | RCT. 2 arms. | |
Participants | Number of children: 28 treatment, 27 control Sex of children: 50.9% M, 49.1% F Age range of children: 6.3 ‐ 18.6 years Mean age range of children: 12.5 years Needle procedure: IV insertion prior to MRI Diagnosis of child: CNS cancer (27% medulloblastoma, 24% CNS glioma, 49% variety of malignant CNS neoplasms) Inclusion criteria: 6 ‐ 18 years, English‐speaking, scheduled to receive an MRI procedure of the brain or spine, received at least 1 previous MRI procedure at hospital within the last 12 months, in remission or had stable disease, or both Exclusion: children who had relapsed or had evidence of progressive disease or had severe cognitive deficits, or both Setting: St Jude’s Children’s Hospital, Tennessee, United States |
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Interventions | 1. CBT: Children received the CBT 1 to 2 hours prior to the procedure. The intervention consisted of filmed modeling (a 15‐minute film depicted the steps involved in preparing for the MRI), breathing exercises (both passive and active exercises), emotive imagery/distraction (focus on emotive or pleasant mental images), behavioral rehearsal (involved practice for starting an IV and lying still inside the MRI), and positive incentive (showing the child a small trophy and saying he/she could win the trophy by “doing the best they could do”). 2. Standard care control (SCC): Children received the standard preparation for the MRI exam at this institution. Prior to their procedure, they had the opportunity to discuss details about the MRI procedure with the technologist and view the magnet. |
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Outcomes | Distress measure:
Adverse events: none mentioned |
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Notes | Parent and staff IV distress ratings were pooled together to create one overall 'observer‐reported distress' outcome. Only outcomes related to the IV (not the MRI) were used in the analyses for this review. The STAI‐C scores were used in this study to assess background variables, therefore they were not included in the analyses for this review. Study dates: study dates not reported Funding: American Lebanese Syrian Associated Charities (ALSAC) and the National Cancer Institute, Cancer Center Support (CORE) Grants CA 21765 and CA 23099 Conflicts of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized ‐ no further details. Insufficient information to permit judgment of 'low' or 'high' risk |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgment of 'low' or 'high' risk |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study participants were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgment of 'low' or 'high' risk |
Other bias | High risk | Multiple potential sources of bias related to study design and other problems |