scholarly journals Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e027864
Author(s):  
Chunmei Zhao ◽  
Yitong Jia ◽  
Zipu Jia ◽  
Xiong Xiao ◽  
Fang Luo
Keyword(s):  
Postoperative Pain ◽  
Study Protocol ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Local Anaesthetics ◽  
Intracranial Surgery ◽  
Intention To Treat ◽  
Incisional Pain ◽  
Randomised Controlled

IntroductionPre-emptive scalp infiltration with local anaesthetics is the simplest and most effective method to prevent postoperative incisional pain. However, local infiltration of an anaesthetic only provides relatively short-term pain relief. Methylprednisolone (MP) treatment, administered as an adjuvant at the wound site, has been shown to provide satisfactory pain management after lumbar laminectomy. However, there is no evidence regarding the efficacy of MP infiltration for the relief of postoperative pain after craniotomy. Currently, postoperative pain after craniotomy in children is undertreated. Therefore, we aim to investigate whether pre-emptive scalp infiltration with ropivacaine (RP) plus MP is superior to RP alone to improve postoperative pain after craniotomy in children.Methods and analysisThe RP/MP versus RP trial is a prospective, single-centre, randomised, parallel-group study of 100 children aged 8–18 years undergoing intracranial surgery. Participants will be randomly allocated to receive pre-emptive scalp infiltration with either RP plus MP or RP alone. The primary outcome will be the cumulative fentanyl dose administered by patient-controlled intravenous analgesia within 24 hours postoperatively. The secondary outcomes will include postoperative Numerical Rating Scale scores, pain control satisfaction scores, length of stay and adverse events. Data will be analysed by the intention-to-treat principle.Ethical approval and disseminationThe study protocol has been approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (Approval Number: KY 2018-066-02). The results will be disseminated in international academic meetings and published in peer-reviewed journals.Trial registration numberNCT03636165; Pre-results.

scholarly journals Reducing arthritis fatigue impact: two-year randomised controlled trial of cognitive behavioural approaches by rheumatology teams (RAFT)

2019 ◽  
Vol 78 (4) ◽  
pp. 465-472 ◽  
Author(s):  
Sarah Hewlett ◽  
Celia Almeida ◽  
Nicholas Ambler ◽  
Peter S Blair ◽  
Ernest H Choy ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Cognitive Behavioural ◽  
Numerical Rating ◽  
Randomised Controlled ◽  
Group Programme

ObjectivesTo see if a group course delivered by rheumatology teams using cognitive-behavioural approaches, plus usual care, reduced RA fatigue impact more than usual care alone.MethodsMulticentre, 2-year randomised controlled trial in RA adults (fatigue severity>6/10, no recent major medication changes). RAFT (Reducing Arthritis Fatigue: clinical Teams using CB approaches) comprises seven sessions, codelivered by pairs of trained rheumatology occupational therapists/nurses. Usual care was Arthritis Research UK fatigue booklet. Primary 26-week outcome fatigue impact (Bristol RA Fatigue Effect Numerical Rating Scale, BRAF-NRS 0–10). Intention-to-treat regression analysis adjusted for baseline scores and centre.Results308/333 randomised patients completed 26 week data (156/175 RAFT, 152/158 Control). Mean baseline variables were similar. At 26 weeks, the adjusted difference between arms for fatigue impact change favoured RAFT (BRAF-NRS Effect −0.59, 95% CI –1.11 to -0.06), BRAF Multidimensional Questionnaire (MDQ) Total −3.42 (95% CI –6.44 to -0.39), Living with Fatigue −1.19 (95% CI –2.17 to -0.21), Emotional Fatigue −0.91 (95% CI –1.58 to -0.23); RA Self-Efficacy (RASE, +3.05, 95% CI 0.43 to 5.66) (14 secondary outcomes unchanged). Effects persisted at 2 years: BRAF-NRS Effect −0.49 (95% CI −0.83 to -0.14), BRAF MDQ Total −2.98 (95% CI −5.39 to -0.57), Living with Fatigue −0.93 (95% CI −1.75 to -0.10), Emotional Fatigue −0.90 (95% CI −1.44, to -0.37); BRAF-NRS Coping +0.42 (95% CI 0.08 to 0.77) (relevance of fatigue impact improvement uncertain). RAFT satisfaction: 89% scored > 8/10 vs 54% controls rating usual care booklet (p<0.0001).ConclusionMultiple RA fatigue impacts can be improved for 2 years by rheumatology teams delivering a group programme using cognitive behavioural approaches.Trial registration numberISRCTN52709998.

scholarly journals Postendodontic Pain after Pulpotomy or Root Canal Treatment in Mature Teeth with Carious Pulp Exposure: A Multicenter Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-14
Author(s):  
Mohammad Jafar Eghbal ◽  
Ali Haeri ◽  
Arash Shahravan ◽  
Ali Kazemi ◽  
Fariborz Moazami ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Pain Relief ◽  
Root Canal ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Mineral Trioxide Aggregate ◽  
Preoperative Pain ◽  
Multicenter Randomized Controlled Trial ◽  
The Mean

This equivalence, randomized, clinical trial aimed to compare the postoperative pain of root canal therapy (RCT) with pulpotomy with mineral trioxide aggregate (PMTA) or calcium-enriched mixture (PCEM) in permanent mature teeth. In seven academic centers, 550 cariously exposed pulps were included and randomly allocated into PMTA (n = 188), PCEM (n = 194), or RCT (n = 168) arms. Preoperative “Pain Intensity” (PI) on Numerical Rating Scale and postoperative PIs until day 7 were recorded. Patients’ demographic and pre-/intra-/postoperative factors/conditions were recorded/analysed. The arms were homogeneous in terms of demographics. The mean preoperative PIs were similar (P=0.998), the mean sum PIs recorded during 10 postoperative intervals were comparable (P=0.939), and the trend/changes in pain relief were parallel (P=0.821) in all study arms. The incidences of preoperative moderate-severe pain in RCT, PMTA, and PCEM arms were 56.5%, 55.7%, and 56.7%, which after 24 hours considerably decreased to 13.1%, 10.6%, and 12.9%, respectively (P=0.578). The time span of endodontic procedures was statistically different; RCT = 69.73, PMTA = 35.37, and PCEM = 33.62 minutes (P<0.001). Patients with greater preoperative pain, symptomatic apical periodontitis, or presence of PDL widening suffered more pain (P=0.002, 0.035, and 0.023, resp.); however, other pre-/intra-/postoperative factors/conditions were comparable. Pulpotomy with MTA/CEM and RCT demonstrate comparable and effective postoperative pain relief.

scholarly journals Electroacupuncture to alleviate postoperative pain after a laparoscopic appendectomy: study protocol for a three-arm, randomised, controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015286 ◽  
Author(s):  
Seunghoon Lee ◽  
Dongwoo Nam ◽  
Minsoo Kwon ◽  
Won Seo Park ◽  
Sun Jin Park
Keyword(s):  
Postoperative Pain ◽  
Laparoscopic Appendectomy ◽  
Pain Control ◽  
Rating Scale ◽  
Acupuncture Treatment ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Acupuncture Points ◽  
Postoperative Pain Control

BackgroundThe purpose of this study is to evaluate the efficacy and safety of electroacupuncture (EA) for postoperative pain after laparoscopic appendectomy compared with sham electroacupuncture (SEA) and no acupuncture treatment.Methods and analysisThis study is a protocol for a three-arm, randomised, patient-assessor-blinded (to the type of acupuncture treatment), controlled, parallel trial. 138 participants diagnosed with appendicitis and scheduled for laparoscopic appendectomy will be randomly assigned to the EA group (n=46), SEA group (n=46) or control group (n=46). The EA group will receive acupuncture treatment at both regional and distal acupuncture points with electrostimulation. The SEA group will receive sham acupuncture treatment with mock electrostimulation. Both EA and SEA groups will receive a total of four treatments 1 hour preoperative, 1 hour postoperative and during the morning and afternoon the day after surgery with the same routine postoperative pain control. The control group will receive only routine postoperative pain control. The primary outcome is the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at 24 hours after surgery. The secondary outcomes are the PI-NRS, analgesic consumption, opioid-related side effects, time to first passing flatus, quality of life and adverse events evaluated 6, 12, 24 and 36 hours and 7 days after surgery.Ethics and disseminationThe study was planned in accordance with the Helsinki Declaration and the Korean Good Clinical Practice Guidelines to protect the participants and was approved by the institutional review board (IRB) of Kyung Hee University Medical Center (KMC IRB-1427–02). The results will be disseminated in peer-reviewed journals and presented at international conferences.Trial registration numberClinical Research Information Service (KCT0001328).

scholarly journals Intramuscular versus oral diclofenac for acute pain in adults with acute musculoskeletal injuries presenting to the ED setting: a prospective, double-blind, double-dummy, randomised controlled trial

2019 ◽  
pp. emermed-2018-208214
Author(s):  
Isma Qureshi ◽  
Sameer A Pathan ◽  
Raheel Sharfeen Qureshi ◽  
Stephen H Thomas
Keyword(s):  
Randomised Controlled Trial ◽  
Pain Score ◽  
Drug Administration ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Musculoskeletal Injuries ◽  
Number Needed To Treat ◽  
Randomised Controlled

ObjectiveThe current study aimed to ascertain differences in early postmedication pain reduction in participants presenting with acute musculoskeletal injuries (MSI) to the ED receiving intramuscular (IM) versus per oral (PO) diclofenac.MethodsThis was a prospective, double-blinded, randomised controlled trial conducted between January and June 2018 at the ED of Hamad General Hospital in Doha, Qatar. Adults (18–65 years of age) presenting to the ED within 24 hours of an acute MSI, who had a triage pain score measured using numerical rating scale of at least five or above were enrolled in this trial. Participants randomised to either IM (75 mg) with oral placebo, or oral (100 mg) diclofenac group with IM placebo using a computer-generated randomised concealed list in blocks of six and eight. The primary objective was to compare the proportion of IM versus PO participants attaining a 50% reduction in pain score at 30 min from t0.Results300 participants were enrolled (150 in the IM diclofenac group and 150 in the PO diclofenac group) in the trial. The primary outcome was achieved in 99.3 (95% CI 96.3 to 100) in the IM group and 86.7 (95% CI 80.2 to 91.7) in PO group. There was an absolute risk difference of 12.7%. This corresponds to a number needed to treat of 8 cases (95% CI 6 to 14) receiving IM rather than the PO diclofenac in order to achieve one additional case of 50% pain reduction within 30 min of drug administration. There were no adverse events experienced in any treatment groups.ConclusionIM diclofenac injection provides rapid analgesia over PO administration of diclofenac. However, given the preparation needed for an IM injection, oral administration may be preferable when and if clinical circumstances allow a choice in non-steroidal anti-inflammatory drug administration route.

scholarly journals Out-patient triple chronotherapy for the rapid treatment and maintenance of response in depression: feasibility and pilot randomised controlled trial

BJPsych Open ◽  
2021 ◽  
Vol 7 (6) ◽  
Author(s):  
David Veale ◽  
Marc Serfaty ◽  
Clara Humpston ◽  
Andriani Papageorgiou ◽  
Sarah Markham ◽  
...  
Keyword(s):  
Rating Scale ◽  
Clinical Sample ◽  
Controlled Trial ◽  
Bright Light ◽  
Light Therapy ◽  
Control Group ◽  
Intention To Treat ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Rapid Treatment

Background Triple chronotherapy (sleep deprivation for 36 h, followed by 4 days of advancing the time of sleep and daily morning bright-light therapy for 6 months) has demonstrated benefits for the rapid treatment of depressive symptoms in four small controlled trials of in-patients. Aims To test the feasibility of recruitment and delivery of triple chronotherapy for out-patients with depression (ISRCTN17706836; NCT03405493). Method In a single-blind trial, 82 participants were randomised to triple chronotherapy or a control intervention. The primary outcome was the number of participants recruited per month and adherence to the protocol. Secondary outcomes included the 6-item Hamilton Rating Scale for Depression (HRSD-6) at 1 week. Timings of observer ratings were baseline and 1, 2, 4, 8 and 26 weeks after randomisation. Results The triple chronotherapy group stayed awake for the planned 36 h and 89.9% adhered to the plan of phase advance of their sleep over the following 4 days. We achieved our recruitment target (60 participants completed the trial within 13 months). There were no reported adverse side-effects. We found a significant difference between the groups by intention-to-treat analysis for the HRSD-6 at weeks 1, 8 and 26. There was a large effect size of Cohen's d = 0.8 on HRSD-6 score at week 1, increasing to d = 1.30 at week 26. A response (≥50% reduction in symptoms) was achieved by 33.3% in the triple chronotherapy group and 16.2% in the control group. This stayed relatively steady until week 26 (35.9 v. 13.9%). Conclusions Triple chronotherapy produced a significant and rapid benefit after 1 week in out-patients with depression that was sustained at 26 weeks. Cost-effectiveness trials with a larger clinical sample are required.

scholarly journals Effect of Intravenous Acetaminophen and Flurbiprofen on Postoperative Pain after Lumbar Disc Surgery

2021 ◽  
pp. 1-7
Author(s):  
Maki Ono ◽  
Yoshiaki Terao ◽  
Yuya Komatsu ◽  
Ayako Shimazaki ◽  
Natsuko Oji ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Lumbar Disc ◽  
Diclofenac Sodium ◽  
Lumbar Disc Surgery ◽  
Skin Closure ◽  
Disc Surgery ◽  
Effective Analgesia

Aims: Lumbar disc surgery is often associated with moderate to severe postoperative pain. Whether non-steroidal anti-inflammatory drugs or acetaminophen provides effective analgesia following lumbar disc surgery remains controversial. This study aimed to determine whether flurbiprofen produces analgesic effects equivalent to those of acetaminophen after lumbar disc surgery. Study Design: Prospective, randomized, open-label, placebo-controlled trial Place and Duration of Study: Department of Anesthesia, Nagasaki Rosai Hospital, Sasebo, Japan, between April 2018 and March 2019. Methodology: We studied 76 patients who underwent elective lumbar disc surgery under general anesthesia. The patients were randomly allocated to one of three groups. Group A (n=25) received 1000 mg of acetaminophen intravenously every 6 h. Group F (n=25) received 50 mg of flurbiprofen intravenously every 6 h. Group C (n=26) received saline intravenously every 6 h as a placebo. Each drug was started before skin closure 18 h after surgery. All patients were anesthetized under total intravenous anesthesia with propofol and remifentanil and received fentanyl before skin closure. Postoperative pain was evaluated using a numerical rating scale (NRS) at 0, 1, 3, 6, 12, 18, and 24 h postoperatively. The patients were administered diclofenac sodium or loxoprofen, as rescue analgesics, as needed. Results: There were no significant differences in patient characteristics among the three groups. There were no significant differences in NRS scores among the three groups during the study period. However, rescue analgesics were administered significantly less frequently in group F than in groups A and C over 12 h and 24 h, respectively. Conclusion: The results of this study showed that flurbiprofen might provide more effective analgesia than acetaminophen following lumbar disc surgery.

scholarly journals Impact of Intravenous Dexmedetomidine on Postoperative Bowel Movement Recovery After Laparoscopic Nephrectomy: A Consort-Prospective, Randomized, Controlled Trial

2021 ◽  
Author(s):  
shanshan huang ◽  
Fuxi Song ◽  
Shuai Hu ◽  
Shaozhong Yang ◽  
Shuqin Wang ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Adverse Effects ◽  
Postoperative Ileus ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Laparoscopic Nephrectomy ◽  
Secondary Outcome ◽  
Bowel Movements ◽  
The Times

Abstract Background Postoperative ileus is a frequent complication after surgery, especially abdominal surgery. Of the factors, sympathetic excitation is the primary factor for postoperative ileus. Sympathetic activation is always increased by the stress of surgery and postoperative pain. It was reported that dexmedetomidine (DEX) lessens pain and inhibits the sympathetic nerve by acting on the locus coeruleus. Therefore we designed our study to observe whether DEX promotes bowel movements in patients after laparoscopic nephrectomy.MethodsOne hundred and twenty patients undergoing laparoscopic nephrectomy were assigned into three groups, group C (normal saline infusion), group D1 (DEX 0.02 µg/kg/h), and group D2 (DEX 0.04 µg/kg/h). The primary outcome was to record the times of first flatus, defecation and eating after surgery. The secondary outcome was postoperative pain accessd by the numerical rating scale (NRS), concerning adverse effects, as well as the duration of the postoperative hospital stay.ResultsThe times of first flatus, defecation and eating in groups D1 and D2 were shorter than those in group C (P<0.01). The NRS scores at 8 h and 24 h after surgery were obviously lower in groups D1 and D2 than in group C (P<0.05). There were no concerning adverse effects (P>0.05).ConclusionDEX in 0.04 µg/kg/h postoperative infusion facilitates bowel movements in patients undergoing laparoscopic nephrectomy.Trial registrationThis trial was registered in a Chinese Clinical Trial Registry (ChiCTR) center on December 23, 2015. The registered number was ChiCTR-IPR-15007628.

scholarly journals Acupuncture for Cancer Related Pain: Protocol for a Pragmatic Randomised Wait-List Controlled Trial

2020 ◽  
Vol 19 ◽  
pp. 153473542097657
Author(s):  
Qi Zhao ◽  
Suyang Zheng ◽  
Geoff P. Delaney ◽  
Eugene Moylan ◽  
Meera R. Agar ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Post Treatment ◽  
Local Health ◽  
Wait List ◽  
Clinical Trial Registry ◽  
Numerical Rating ◽  
Randomised Controlled

Background: Acupuncture has been proved effective for cancer related pain (CRP) in China, America and some other countries. However, there is relative lack of evidence to support the use of acupuncture for CRP in Australia. Objectives: To assess the effectiveness and safety of acupuncture for management of CRP in a real-world setting and to understand cancer patients’ experience of undergoing acupuncture for CRP. Methods: A pragmatic randomised controlled trial will be conducted in South Western Sydney Local Health District (SWSLHD) in NSW, Australia. Adults with cancer related pain (n = 106) will be randomised in a 1:1 ratio to receive the acupuncture intervention up front versus after a wait list period of 4 weeks. Pain level (by Numerical Rating Scale), analgesic use, auricular acupressure frequency and adverse events will be assessed at baseline, mid-treatment and post-treatment. Expectancy on trial outcome (by Credibility and Expectancy questionnaire) will be assessed at baseline. The perspective of the participants (by an interview) will be recorded after the last intervention. Expected outcomes: We hypothesise that acupuncture will relieve cancer related pain at mid-treatment and post-treatment. We also hypothesise that few adverse events will be provoked by acupuncture. Trial registration: Australia New-Zealand Clinical Trial Registry (ACTRN12620000325909).

scholarly journals Rating of four different foods in women with hyperemesis gravidarum: a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e046528
Author(s):  
Gi Ni Tan ◽  
Peng Chiong Tan ◽  
Jesrine Gek Shan Hong ◽  
Balaraman Kartik ◽  
Siti Zawiah Omar
Keyword(s):  
Rating Scale ◽  
Hyperemesis Gravidarum ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Random Order ◽  
University Hospital ◽  
White Bread ◽  
Significant Difference ◽  
Numerical Rating ◽  
Randomised Controlled

ObjectiveTo evaluate four foods in women with hyperemesis gravidarum (HG) on their agreeability and tolerability.DesignProspective, randomised, within-subject cross-over trial.SettingSingle-centre, tertiary, university hospital in Malaysia.Participants72 women within 24-hour of first admission for HG who were 18 years or above, with confirmed clinical pregnancy of less than 16 weeks’ gestation were recruited and analysed. Women unable to consume food due to extreme symptoms, known taste or swallowing disorder were excluded.InterventionsEach participant chewed and swallowed a small piece of apple, watermelon, cream cracker and white bread in random order and was observed for 10 min after each tasting followed by a 2 min washout for mouth rinsing and data collection.Outcome measuresPrimary outcome was food agreeability scored after 10 min using an 11-point 0–10 Visual Numerical Rating Scale (VNRS). Nausea was scored at baseline (prior to tasting) and 2 and 10 min using an 11-point VNRS. Intolerant responses of gagging, heaving and vomiting were recorded.ResultsOn agreeability scoring, apple (mean±SD 7.2±2.4) ranked highest followed by watermelon (7.0±2.7) and crackers (6.5±2.6), with white bread ranked lowest (6.0±2.7); Kruskal-Wallis H test, p=0.019. Apple had the lowest mean nausea score and mean rank score, while white bread had the highest at both 2 and 10 min; the Kruskal-Wallis H test showed a significant difference only at 10 min (p=0.019) but not at 2 min (p=0.29) in the ranking analyses. The intolerant (gagged, heaved or vomited) response rates within the 10 min study period were apple 3/72 (4%), watermelon 7/72 (10%), crackers 8/72 (11%) and white bread 12/72 (17%): χ2 test for trend p=0.02.ConclusionSweet apple had the highest agreeability score, the lowest nausea severity and intolerance–emesis response rate when tasted by women with HG. White bread consistently performed worst.

scholarly journals Cognitive–behavioural group therapy for adolescents with ADHD: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e032839 ◽  
Author(s):  
Torunn Stene Nøvik ◽  
Anne-Lise Juul Haugan ◽  
Stian Lydersen ◽  
Per Hove Thomsen ◽  
Susan Young ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Group Therapy ◽  
Study Protocol ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Treatment As Usual ◽  
Cognitive Behavioural ◽  
Child Psychiatric ◽  
Randomised Controlled

IntroductionPersistence of attention deficit hyperactivity disorder (ADHD) into adolescence is a significant burden to patients. Clinical guidelines recommend non-pharmacological therapies, but the evidence to support this recommendation is sparse. This study aims to evaluate the effect of a 12-week group cognitive–behavioural therapy (CBT) programme for adolescents with ADHD aged 14–18 years, who still have impairing symptoms after treatment with medication. We will study the effect of the treatment on ADHD symptoms and examine moderators and mediators of the effect of the treatment on ADHD.Methods and analysisWe conduct a randomised controlled trial of CBT group therapy in adolescents with ADHD recruited from child psychiatric outpatient units in Mid-Norway. 99 adolescents who met inclusion criteria and consented to participation have been randomised to a 12-week group intervention or to a control group receiving treatment as usual. Assessments are made at admission to the clinic, preintervention, postintervention and at a 9-month follow-up, obtaining adolescent, parent and teacher reports. Clinicians blinded to group allocation rate all participants as to their functioning preintervention and at the two postintervention assessment points. The primary outcome is change in symptom scores on the ADHD Rating Scale-IV.Ethics and disseminationThe Regional Committee for Medical and Health Research Ethics in South East Norway approved the study protocol (2015/2115). We will disseminate the findings in peer-reviewed publications and conference presentations, to user organisations and at courses attended by families and professionals. Two PhD students will publish and defend dissertations relating to the study. Planned publications include primary and secondary outcomes and patient satisfaction with the treatment. Furthermore, we plan to publish a manual of CBT group therapy in adolescent ADHD to benefit treatment of patients in Norway and elsewhere.Trial registration numberNCT02937142

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