Web-based open source application for the randomization process in clinical trials: RANDI2

Schrimpf, Daniel; Plotnicki, L.; Pilz, Lothar R.

doi:10.5414/cpp48465

Cited by 19 publications

(15 citation statements)

References 4 publications

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“…Randomization was stratified by centre and conducted by using the randomization software "RANDI 2". (24) The randomization program was applied by an independent assistant at the University Hospital Heidelberg. Data analysts were blinded to assignment.…”

Section: Randomisation and Maskingmentioning

confidence: 99%

A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study

Wild

Hünnemeyer

Sauer

et al. 2015

Surgery for Obesity and Related Diseases

159

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Section: Randomisation and Maskingmentioning

confidence: 99%

A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study

Wild

Hünnemeyer

Sauer

et al. 2015

Surgery for Obesity and Related Diseases

159

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“…15 Block randomization was used to stratify on the basis of sex, BMI (>25), and current smoking status (yes/no). 15 Block randomization was used to stratify on the basis of sex, BMI (>25), and current smoking status (yes/no).…”

Section: Sample Size Analysis and Randomizationmentioning

confidence: 99%

Early Use of Low Residue Diet Is Superior to Clear Liquid Diet After Elective Colorectal Surgery

Lau

Phillips²,

Bresee

et al. 2014

Annals of Surgery

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“…Recruitment will be done consecutively until a sample size of n = 40 patients is reached (control group: n = 20; intervention group: n = 20). Randomization will be done centrally with the established randomization program RANDI 2 [44,45] after patient inclusion by an independent person not involved in treatment or assessment. Allocation concealment will be ensured, as this person will not release the randomization code until the patient has been recruited into the trial, which takes place after all baseline assessments have been completed.…”

Section: Methods and Designmentioning

confidence: 99%

Effects of eye movement desensitization and reprocessing (EMDR) on non-specific chronic back pain: a randomized controlled trial with additional exploration of the underlying mechanisms

Tesarz

Gerhardt

Leisner

et al. 2013

BMC Musculoskelet Disord

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BackgroundNon-specific chronic back pain (CBP) is often accompanied by psychological trauma, but treatment for this associated condition is often insufficient.Nevertheless, despite the common co-occurrence of pain and psychological trauma, a specific trauma-focused approach for treating CBP has been neglected to date. Accordingly, eye movement desensitization and reprocessing (EMDR), originally developed as a treatment approach for posttraumatic stress disorders, is a promising approach for treating CBP in patients who have experienced psychological trauma.Thus, the aim of this study is to determine whether a standardized, short-term EMDR intervention added to treatment as usual (TAU) reduces pain intensity in CBP patients with psychological trauma vs. TAU alone.Methods/designThe study will recruit 40 non-specific CBP patients who have experienced psychological trauma. After a baseline assessment, the patients will be randomized to either an intervention group (n = 20) or a control group (n = 20). Individuals in the EMDR group will receive ten 90-minute sessions of EMDR fortnightly in addition to TAU. The control group will receive TAU alone. The post-treatment assessments will take place two weeks after the last EMDR session and six months later.The primary outcome will be the change in the intensity of CBP within the last four weeks (numeric rating scale 0–10) from the pre-treatment assessment to the post-treatment assessment two weeks after the completion of treatment.In addition, the patients will undergo a thorough assessment of the change in the experience of pain, disability, trauma-associated distress, mental co-morbidities, resilience, and quality of life to explore distinct treatment effects. To explore the mechanisms of action that are involved, changes in pain perception and pain processing (quantitative sensory testing, conditioned pain modulation) will also be assessed.The statistical analysis of the primary outcome will be performed on an intention-to-treat basis. The secondary outcomes will be analyzed in an explorative, descriptive manner.DiscussionThis study adapts the standard EMDR treatment for traumatized patients to patients with CBP who have experienced psychological trauma. This specific, mechanism-based approach might benefit patients.Trial registrationThis trial has been registered with ClinicalTrials.gov (NCT01850875).

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Web-based open source application for the randomization process in clinical trials: RANDI2

Cited by 19 publications

References 4 publications

A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study

A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study

Early Use of Low Residue Diet Is Superior to Clear Liquid Diet After Elective Colorectal Surgery

Effects of eye movement desensitization and reprocessing (EMDR) on non-specific chronic back pain: a randomized controlled trial with additional exploration of the underlying mechanisms

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