Study design
This is a two-arm parallel randomized controlled trial led by an expressive art therapist. Infertile women who meet the inclusion criteria will be recruited. After providing written informed consent, participants will be assigned to either the control group or intervention group by using a random number table method. The allocation ratio is 1:1. The trial follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). The schedule of enrolment, interventions, and assessments is presented in a SPIRIT figure (Fig. 1).
Schedule of enrolment, interventions, and assessments, according to SPIRIT 2013
Participants
Participants will be recruited from West China Second Hospital of Sichuan University, which is a women and children’s medical center in West China serving more than 5 provinces. Women are eligible if they (1) have been diagnosed with infertility, (2) will choose hysteroscopic surgery or/and laparoscopic surgery, and (3) have the ability to read and write in Chinese. Participants will be excluded if they have been diagnosed with mental illness. If participants from the intervention group and the control group are found to be sharing the same room, both will be excluded from the study to prevent any potential contamination.
Intervention
Expressive art therapies will be led by the certified international expressive art therapist. The interventions include progressive muscle relaxation training, music meditation, and drawing therapy. The intervention time points include the first 24 h of admission (t1) and the first 24 h after surgery (t2). After baseline investigation (t0), participants in the intervention group will receive progressive muscle relaxation training (10 min), music meditation (10 min), and drawing therapy (40 min). The total duration of intervention is approximately 1 h. Participants in the intervention group and control group will receive general health education and routine nursing care. General health education and routine nursing care are standard practices in our hospital. By using them as the control group, we can establish a baseline for comparison, which makes it easier to evaluate the effectiveness of our intervention. Within the first 24 h after surgery, participants in the intervention group will perform progressive muscle relaxation and music meditation under guidance. At discharge (t3), participants in the two groups will complete the questionnaires. Participants are free to leave the study at any time for any reason without consequences. To improve adherence, all participants will be provided with guidance when they sign the informed consent form and commit to attending on the scheduled intervention time points.
Measurement
A self-designed questionnaire will be used to collect sociodemographic information. The Hospital Anxiety and Depression Scale (HADS) is a self-reported screening questionnaire that detects mild anxiety and depression. It consists of 14 items, 7 items assessing anxiety (HADS-A), and 7 items assessing depression (HADS-D). Each item is scored on a 4-point Likert scale, ranging from 0 to 3, producing a sum score of 0 to 21 on each subscale. High scores indicate more severe symptoms [17]. The Mandarin version of the HADS was reliable and valid for the Chinese population. Cronbach’s α coefficients of the HADS-A and HADS-D subscales were 0.753 and 0.764, respectively [18, 19].
The Fertility Problem Inventory (FPI) was developed by Newton et al. in 1999 [20]. The FPI is a 46-item self-rating scale assessing the level of infertility-related stress. Each item is scored on a 6-point Likert scale, ranging from 1 to 6. The FPI includes 5 dimensions: social concern (10 items), relationship concern (10 items), need for parenthood (10 items), rejection of childfree lifestyle (8 items), and sexual concern (8 items). Global stress is calculated by summing five subscale scores. The total scores range from 46 to 276. Higher scores indicate higher infertility-related stress. The Mandarin version of the FPI (M-FPI) was reliable and valid for Chinese infertile couples. The test–retest reliability of the FPI was 0.83 (female), and Cronbach’s α coefficient was 0.927 [5, 21].
Primary and secondary outcomes
The primary outcome is the level of infertility-related stress measured by the Fertility Problem Inventory (FPI), before participants are discharged from the hospital. The secondary outcomes are the levels of anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS) before participants are discharged from the hospital.
Data collection and management
The Hospital Anxiety and Depression Scale (HADS) and Fertility Problem Inventory (FPI) will be used to investigate the anxiety, depression and infertility-related stress of all participants at admission (t0) and at discharge (t3) from the hospital. The questionnaire will be administered via Wenjuanxing, the most popular web-based survey platform in China. Completeness checks were performed by allowing submission only after mandatory answering of all questions. Participants scan the QR code to receive the questionnaire. The platform promised to keep all data strictly confidential. Only researchers on this team (Huaxuan You and Anjiang Lei) will have access to the dataset. All the information will be coded without revealing personal data, and handled confidentially.
Sample size
According to the pilot study, the standard deviations of FPI in the intervention group and control group were 22.91 and 29.01, respectively, and the means of FPI in the intervention group and control group were 144.29 and 159.31, respectively. We assumed that the number of patients in the intervention group was the same as that in the control group. The calculated sample size of 52 participants per group would provide 80% power with a two-tailed alpha error of 0.05. Estimating a dropout rate of approximately 5%, we will recruit at least 55 participants in each group.
Randomization
The participants were assigned to the intervention group or control group by the random number table method. A computer-generated table of random numbers with parity matching was used. The obtained numbers were assigned to the continuously included participants. Participants with even numbers were assigned to the intervention group, and those with odd numbers were assigned to the control group. The generated random distribution sequence was placed in sequentially coded envelopes. After determining the eligibility of the participant, the researcher (You Huaxuan) opened the envelope and assigned the participant to the intervention group or control group.
Blinding
Medical staff will be blinded to group allocation. The researcher (Chunyang Xi) who collected data will be blinded to group allocation. Other researchers and participants will be aware of the group allocation. The researcher who collected data will not be allowed to unblock the blinding.
Statistical methods
The qualitative data (demographic characteristics) will be statistically described by number (n) and percentage (%) and statistically be inferred by chi-square test. The Shapiro–Wilk test will be used to assess the normality of our data. This test is suitable for small to medium-sized samples and will help us determine whether the data follows a normal distribution. The quantitative data (scores of HADS and FPI) will be described by mean/median and standard deviation (SD)/interquartile range (IQR) and be inferred by t test/rank sum test. In all analyses, a P value of < 0.05 indicates statistical significance. To handle protocol non-adherence in our randomized controlled trial, we will use an intention-to-treat (ITT) analysis. Additionally, we will conduct a per-protocol (PP) analysis to include only those participants who fully adhered to the study protocol. By comparing ITT and PP results, we aim to understand the impact of adherence on study outcomes. All instances of non-adherence will be documented and considered during data analysis and interpretation. SPSS 21.0 (SPSS Inc., Chicago, IL) will be used for statistical analysis.
Data monitoring
All the interventions applied in this study have been used in clinical practice and are not potentially harmful, so the data monitoring committee is not included in this study. Any unexpected adverse events that occurred during the intervention period will be reported to an experienced psychologist who will not be involved in this trial. To ensure the safety and effectiveness of the study, we will conduct an interim analysis when approximately 50% of the participants have completed the trial.
Ethics approval and consent to participate
This study was approved by the ethics committee of West China Second University Hospital (No. 2022283). All amendments proposed by the ethics committee were sent to the ethics committee before study approval. One researcher (Anjiang Lei) will obtain the informed consent from all participants. All data provided to our study will be kept in strict confidence, and none of the participants’ identifying information will be reported. All procedures in this study will be conducted in accordance with the ethical standards of the responsible committee on human study and with the Helsinki Declaration and later revision.
Dissemination plans
The results of this study will be published in a scientific journal. The selection of the authorship is based on several considerations, including the following items: contribute to the study design, data collection, data analysis, data interpretation, manuscript drafting, and manuscript revising. Scientific presentations for researchers, healthcare practitioners, and/or the public present another forum for dissemination of our results.
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