The current research is a clinical trial to determine the effect of cognitive-emotional intervention on the psychological distress of mothers of children with cancer, which has been registered with the code number IRCT20160924029954N12. The studied population consisted of all mothers of children with cancer who were referred to the chemotherapy ward of Imam Ali Hospital in Zahedan in 2018.
Inclusion criteria for mothers consisted of having at least 20 years of age, minimum literacy, lack of cognitive impairments and psychiatric disorders, and no crisis occurring in the last six months except for child cancer. Inclusion criteria for children with cancer were age up to 12 years, receiving at least one course of chemotherapy, and no metastasis, according to records. More than one missing session in the Cognitive-Emotional Training Program, increasing severity of disease or critical patient status during the study due to metastasis, or any traumatic event affecting the mother’s psychological status were the most important exclusion criteria.
The sample size was estimated at 42 cases according to the mean and standard deviation of psychological status of mothers of children with leukemia in the study by Zafrian Moghaddam et al. (
16) with a 95% confidence interval and 80% statistical test power. To ensure the adequacy of sample size and to consider probable loss, 50 individuals in each group and 100 subjects in total were determined (
16).
Z1-α/2 = 1.96; S1 = 17.4; = 32.1; Z1-β = 0.85; S2 = 19.9; = 43.6.
The data collection tool was a two-part questionnaire. The first section contained the mother and child demographic information as well as disease information. The second part was Kessler’s psychological distress scale. The Kessler Psychological Distress scale (K-10) was developed in 1992 by Kessler et al. (
17) to screen the general population. It was specified in subsequent studies that its 10-item form was more effective than other 6-item formats for identifying mood and anxiety disorders. It is also useful for monitoring and measuring the impact of psychological interventions and treatments. This tool has ten items that examines a person’s mental state over the past few weeks. The questions on this form are based on a Likert scale from “never” to “always” and are scored from 0 to 4. Therefore, the maximum score at K-10 is 40, and minimum is 0. A higher score indicates higher psychological distress. This tool does not target a specific psychological disorder, but it generally identifies the level of anxiety and depressive symptoms that a person has experienced over the past few weeks (
17). The validity and reliability of this tool were verified by Yaghubi (
18) in Iran. Based on his factor analysis, the questionnaire was confirmed to be single-factor, which had a positive and significant relationship with the score of general health. Its best cut-off point was obtained 8. Cronbach’s alpha and its reliability coefficients were 0.93 and 0.91, respectively (
18). This tool has been used to measure psychological distress in mothers of children with cancer in Iran by Lotfi Kashani et al. (
7). In this study, the reliability of this instrument was confirmed by Cronbach’s alpha (0.82).
It was referred to the university-related hospital after approving the design and obtaining licenses, the Vice-Chancellor of research and technology. First, eligible participants were selected by identifying children with cancer referred to the chemotherapy department and mothers with the desired characteristics of the target population, using convenient sampling. Informed consent was obtained from mothers to participate in the study. A total of 126 individuals were examined, 26 individuals (15 due to not meeting inclusion criteria, 11 due to decline to participate) were excluded. As a result, the study was conducted and followed up on 100 samples (
Figure 1). Then, the selected mothers were randomly assigned to the intervention and control groups. First, a total of 100 colored balls, identifying the study groups (red ball = intervention, white ball = control), were first prepared (Random allocation rule). Then, the group to which each woman belonged was determined based on the color of the ball picked out of the vase. As the eligible subjects were determined gradually, one of the extracted list numbers was allocated to the selected mothers. The mothers of both groups received pre-test by completing the Kessler scale questionnaire. In case the mothers were assigned to the intervention group, they would receive a 5-session emotional, cognitive training program (two sessions per week) in the form of small groups based on the content specified in
Table 1.
Flow chart of participants through each stage of randomized clinical trial
| Session | Educational content |
|---|
| First | Getting familiar, introducing and expressing group rules, disease overview, psychosocial consequences and treatment process, normalizing emotional reactions to cancers. |
| Second | Training and practicing techniques of emotional disclosure, emotion drain, and self-regulation of emotions. |
| Third | Fears and concerns related to cancer, facilitating and practicing cognitive processing and conscious rumination. |
| Fourth | Reviewing the positive achievements and dimensions as well as the negative aspects of cancer diagnosis, the development of values and the prioritization of new values, and the redefinition of goals and the creation of a new philosophy of life. |
| Fifth | Spirituality, patience training, and positive thinking. Conclusion. |
Overall, 16 weeks after the end of the training sessions, the research questionnaires were completed again as a post-test by referring to the home or making an appointment in the ward. If the mothers were assigned to the control group, they would receive no intervention other than routine chemotherapy care, and the necessary coordination (address and telephone) would be provided to the mothers for the post-test. At the same 16-week interval, a post-test from the control group was also performed. However, after the end of the study, recommendations were offered from the educational content to the control group.
The principles of Cognitive Emotional Intervention used in this study were previously studied and used in a study by Hamidian et al. (
13,
19,
20). The content of the intervention was provided and designed Primarily after studying the books and articles related to the subject and focusing on the Psychotherapy program by Ramos et al. (
12). Then, five experts from the academic field of clinical psychology, health psychology, counseling, nursing, and oncology were consulted to increase the functional aspect. Their opinions were collected and reviewed by the research team, and the last educational content was finalized. Intervention was performed by a nurse with M.A in psychiatric nursing with clinical experience in oncology and cancer wards under the supervision of a person with a PhD in counseling. Data were analyzed after being collected by descriptive and inferential statistics using SPSS-22 software. The significance level in this study was considered (P = 0.05).
Data normality was assessed by the Shapiro-Wilk test. A chi-square test was used to compare the qualitative variables of the two groups. An Independent t-test was used to compare the quantitative variables of the two groups, and paired t-test was implemented for comparisons before and after applying intervention in each group.
The present study was approved by the Ethics Committee of Zahedan University of Medical Sciences (code: IR.ZAUMS.REC.1397.193). The most important ethical considerations in this study consisted of providing information about the study, obtaining written consent, being free to withdraw at any stage of the research, answering potential questions over the phone, and ensuring the confidentiality of the obtained information.