Touyz 1998.
Methods | DETAILS OF STUDY AIM OF INTERVENTION: to reduce pain and improve pain management. AIM OF STUDY: to determine whether telephone consultation influenced patients' perception of and reaction to pain after periodontal surgery. STUDY DESIGN: CCT. METHODS OF RECRUITMENT OF PARTICIPANTS: during a 4 year period patients who presented to the division of periodontology of a general hospital and who fulfilled inclusion criteria were admitted to the study. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: moderate to severe peridontal disease (class 3 and 4), diagnosed as adult cause‐related peridontitis, root planning and subsequent periodontal surgical pocket reduction or prescribed elective preprosthetic periodontal surgery, systemic health,age 30 to 70 years, no history of mental disease, no medication for at least 1 month prior to the procedure. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: not specified. INFORMED CONSENT OBTAINED? no. ETHICAL APPROVAL? unclear. FUNDING: unclear. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: inadequate. EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: not done. METHOD OF CONCEALMENT OF ALLOCATION: not done. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: no. INTENTION TO TREAT ANALYSIS: not stated. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: not stated. STATISTICAL METHODS AND THEIR APPROPRIATENESS: student t‐test. CONSUMER INVOLVEMENT: not stated. |
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Participants | DESCRIPTION: surgery patients. GEOGRAPHIC LOCATION: Canada. SETTING: discharged home from an acute care setting. NUMBER OF PARTTICIPANTS: ELIGIBLE: 152. RANDOMISED TO INTERVENTION: 59. RANDOMISED TO CONTROL: 59. INCLUDED IN ANALYSIS INTERVENTION GROUP: 59. INCLUDED IN ANALYSIS CONTROL GROUP: 59. AGE: RANGE OR MEAN (SD): 50 (2). GENDER (% MALE): 46. ETHNICITY: unclear. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: periodontitis. OTHER HEALTH PROBLEM/S: none. TREATMENT RECEIVED/RECEIVING: periodontal surgery. OTHER SOCIAL/DEMOGRAPHIC DETAILS: |
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Interventions | DETAILS OF INTERVENTION: the intervention group patients were called no later than 24 hours after the procedure. The telephone interviewer was either the assisting student or the supervisor dentist, who then systematically inquired about 10 points (well‐being of patient, the return to normal and loss of analgesia, jaw swelling, wound bleeding, whether the wound was painful, acquisition and use of mouthwash and analgesics, the need for a soft balanced diet, necessity of sustained oral hygiene, confirmation of the next week's appointment and reassurance about the reaction and pain). The interviewer was instructed to be sympathetic, to reassure patients that whatever reaction they were having was within the range of expected normal limits and to be positive about a successful outcome. DETAILS OF CONTROL: usual care. CO‐INTERVENTION? no. DETAILS OF CO‐INTERVENTIONS: DELIVERY OF INTERVENTION Frequency: 1. First time at day 1 after discharge. Period: PROVIDERS: dentist. INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: unclear. |
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Outcomes | NUMBER OF OUTCOMES: 3 OUTCOME / TOOL / TOOL VALIDATED / METHOD OF ASSESSMENT / TIME OF ASSESSMENT A.Psycho‐social health of patients (uncertainty, anxiety, informational needs, mood, coping, quality of life, social activity, ..): B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): Selfcare deficits / self‐developed / no / telephone interview / 6 weeks after discharge. Blood glucose level / Hba1c‐level / unclear / blood sample / 3 months after discharge. C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): Knowledge / Diabetes knowledge scale (Dunn,1984) / yes / telephone interview / 6 weeks after discharge. D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..): |
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Notes | ·CHANGES IN TRIAL PROTOCOL ·CONTACT WITH AUTHOR ·POWER CALCULATION? ·RECORD IF THE STUDY WAS TRANSLATED FROM A LANGUAGE OTHER THAN ENGLISH. ·RECORD IF THE STUDY WAS A DUPLICATE PUBLICATION. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | High risk | C ‐ Inadequate |