Arslan‐Ozkan 2013.
| Methods | Randomised controlled trial | |
| Participants | Married infertile women at the University hospital, infertility centre in Antalya, Turkey. The women were between 18 and 45 years old, were diagnosed with primary infertility, and were able to speak, read, and write in Turkish. Exclusion criteria were: secondary infertility, diagnosed with a chronic disease, under the age of 18 or above 45. 120 women were randomised into the intervention group (n = 60) and the control group (n = 60) |
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| Interventions | The women in the intervention group received 45 to 90 minutes of Watson's nursing care programme including counselling, relaxation exercises, a music CD, a booklet, and a back massage. The attentional control group received usual care, including regular interviews. Following the final test, the control group received relaxation exercises, a music CD, and a booklet. The interventions were delivered during fertility treatment, individually, face to face, by a nurse | |
| Outcomes | Distress (measured by Infertility Distress Scale) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Simple randomisation was performed by a statistician using SAS version 8.2 (SAS Institute 2001) |
| Allocation concealment (selection bias) | Low risk | A sealed envelope method was used. Women were blinded to treatment allocation |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk | Participants were blinded, attentional control group. Personnel not blinded. Personnel could have influenced the participants |
| Blinding of participants and personnel (performance bias) Objective outcomes | Unclear risk | Not applicable |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | The investigator was not blinded |
| Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Not applicable |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition rate was 12.5% (15/120 were lost to follow‐up). Last observation carried forward method was used, but hard to see how this would apply to pretest and post‐test data There was no significant difference between the intervention and control group in terms of attrition |
| Selective reporting (reporting bias) | Unclear risk | Unclear without access to the protocol |
| Other bias | Low risk | No other obvious sources of bias |