Irani 2015.
Study characteristics | ||
Methods | Quasi‐randomised clinical trial, single‐blinded, Iran. | |
Participants | 80 women referred to the maternity ward for electiveCS under spinal anaesthesia. Participants having basic education, full‐term pregnancy, having 2 or 3 parities, healthy baby, first minute Apgar score of above 7, healthy skin in the massage area, full consciousness after the surgery, willingness to receive massage, no addiction, not having medical conditions such as diabetes, cardiovascular diseases, psychological, sensory and motor disorders, visual or hearing impairment, not having healthy feet and hands or history of severe emotional crisis such as death, migration or divorce during the last 6 months. Participants were randomly assigned to a control (n: 40) and intervention group (n: 40). | |
Interventions | In the intervention group, the massage was performed for 20 minutes on participant’s extremities (5 minutes for each). The main specialised massage techniques included rotational friction movements, stretching, grasping and flexing on different parts of hands and feet from wrist to toes without focusing on a certain point. In the control group, in the other group, the researcher went to the participants’ bedside for 20 minutes, and had an informal chat with them. | |
Outcomes | Pain, anxiety and vital signs of participants after CS. We employed demographic, observation and examination checklists and VAS for measuring pain and anxiety (with zero representing no pain and anxiety and 10 (100 mm) indicating intense and unbearable pain and anxiety). Four hours following the surgery, the massage intervention was given to the experimental group, by the researcher who them measured pain and anxiety 60 and 90 minutes after the massage. | |
Notes | Funding sources: this study was extracted from a research project, approved by Mashhad University of Medical Sciences and Health Services (code: 910071), and was sponsored by the Research Department of the university. Setting: Omolbanin Hospital, Mashhad, Iran. Conflicts of interest: authors declare no conflicts of interest. Dates of trial: July to September of 2013. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Selected through convenience sampling method. |
Allocation concealment (selection bias) | High risk | Participants were randomly assigned to a control and intervention group using colour cards. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It was not possible to blind participants. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The levels of pain and anxiety were assessed by the researcher’s co‐worker, who was blindfolded during the randomisation process. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no losses after randomisation. |
Selective reporting (reporting bias) | High risk | 1 of the proposed outcomes (vital signs) was not presented in results. |
Other bias | Low risk | We do not suspect any other bias related to this study. |