3.4. Procedures
This study was approved by the Ethics Committee of Alborz University of Medical Sciences (Karaj, Iran). The ethical code number was 1395.13. The study was also registered in the Iranian Registry of Clinical Trials (code: IRCT2016051427728N1). Convenience sampling was used to select the participants. For this purpose, the researcher visited the NICU, identified eligible mothers, provided them with the objectives of the study, and asked them to sign an informed consent form, if they were willing to participate. The selected females were then assigned to the intervention (PTSD counseling + routine care counseling) and control (routine care counseling + educational package containing the topics discussed in the PTSD counseling sessions) groups. Eight (twice weekly) sessions of routine counseling (routine infant care) were held for both groups and it included:
Session 1: Information about the hospitalized infant, such as the type of disease and the diagnostic and therapy methods used.
Session 2: Information about the disease symptoms and consequences.
Session 3: Obtaining knowledge and skills about nutrition.
Session 4: Obtaining knowledge and skills about moving and positioning.
Session 5: Obtaining knowledge and skills about hygiene and infection control.
Session 6: Obtaining knowledge and skills about temperature and how to clothe the infant.
Session 7: Obtaining knowledge and skills about the infant’s behavior.
Session 8: Obtaining knowledge and skills on how to interact with the infant.
This package was prepared by Kowsar Teaching Hospital and used for all patients.
The package for PTSD counseling was prepared by an expert panel, including a psychologist, psychiatrist with a cognitive-behavioral approach. The topics discussed in the intervention group and in the package for the control group were as follows:
Session 1: Introduction, discussing group rules and objectives of group therapy, building relationships between mothers, and getting feedback.
Session 2: Asking mothers to discuss the psychological aspects of their feelings and thoughts about the hospitalization of their infants while observing the limitations of a support group, psychological adjustment and emotional release within a supportive environment, and trying to combine the feelings of all group members.
Session 3: Discussing the definition and signs of stress and explaining stress relief techniques for eliminating the signs of stirred emotions.
Session 4: Evaluating the effects of cognition and thoughts on stress responses, advising the participants on how to identify their negative self-talks, emphasizing the significance of coping skills, such as stress management strategies, and discussing how different individuals deal with various stressful events.
Session 5: Discussing stressful self-talk, helping the participants use self-talk as an effective coping strategy, and reviewing stress relief exercises discussed in previous sessions.
Session 6: Focusing on problem-solving skills and asking each mother to provide a description of her problem.
Session 7: Discussing and evaluating alternative solutions and choosing the best one.
Session 8: Examining the efficacy of each solution and readjusting them when necessary.
The duration of the sessions ranged between 40 and 60 minutes in both groups. For ethical considerations, at the end of the last session, the control group also received the educational package, containing topics discussed in the counseling sessions of the intervention group.
The questionnaire was completed by the mothers before the intervention. The obtained scores were considered as both the baseline scores and a standard for ensuring that they met the inclusion criteria. The questionnaire was again completed immediately and three weeks after the intervention (to examine the persistence of the effects of the intervention). Overall, three women from the intervention group and six from the control group withdrew from the study. These women were all excluded as they did not attend all sessions (in one case, however, the participant’s infant died). The total number of the participants was, hence, 81 (
Figure 1).
Data analysis was performed using the SPSS 19.0 software (SPSS Inc., Chicago, IL, USA). Independent t, Mann-Whitney, and Friedman test, along with the generalized estimating equation (GEE), were applied to analyze the data.