| Background: Disease-specific distress refers to the range of negative emotional responses that patients experienced related to the disease.Unlike mental illnesses such as anxiety and depression,disease-specific distress focuses more on different sources of distress,which can help formulate specific interventions.Existing diabetes distress assessment tools were designed specifically for people with type 1 or type 2 diabetes,and did not take into account specific emotional responses associated with pregnancy,such as concerns about fetal health,indicating that these assessment tools were not suitable for comprehensive assessment of disease-specific distress in pregnant women with gestational diabetes mellitus.Therefore,the development of Gestational Diabetes Mellitus Distress Scale is helpful for clinical medical staff to accurately assess the sources and degree of gestational diabetes mellitus distress and to develop targeted intervention measures.Objective: The purpose of this study was to develop the Gestational Diabetes Mellitus Distress Scale and provide reference basis for formulating targeted intervention measures.Methods: This study adopted the mixed-method study design,including four phases: item pool development,experts’ evaluation,pre-testing,and scale reliability and validity evaluation.Phase 1: The item pool of the scale was developed through qualitative research and literature review.Phase 2: The scale was evaluated through three rounds of expert consultation.The items and dimensions of the scale were modified and supplemented according to the expert opinions,and the content validity index and content validity ratio of the scale and each item were calculated.Phase 3: The scale was further refined through two rounds of cognitive interviewing.Phase 4: A questionnaire survey was conducted among pregnant women with gestational diabetes mellitus by convenience sampling method and retest was conducted within two weeks to evaluate the reliability and validity of the scale.The indices of reliability and validity included content validity,construct validity,concurrent validity,internal consistency reliability and stability.Results: Phase 1: Through qualitative research,literature review and group discussion,five dimensions of gestational diabetes mellitus related distress,complications related distress,disease self-management related distress,interpersonal relationship related distress and medical services related distress were formed,with a total of 137 items.Phase 2: After three rounds of content validity evaluation by 10 experts,the revised scale was divided into five dimensions,including diagnosis itself related distress,complications and prognosis related distress,disease self-management related distress,interpersonal relationship and support related distress,and medical services related distress,with a total of 53 items.The item-level content validity index and content validity ratio were 0.90~1.00 and 0.80~1.00,respectively.The scale-level content validity index and content validity ratio were 0.98 and 0.91,respectively.Phase 3: After two rounds of cognitive interviewing,two items were deleted,leaving 51 items.Phase 4: A total of 261 valid samples were collected and 53 samples were retested.A total of 20 items were deleted from the scale,and 31 items remained after item reduction.Five common factors were identified by the exploratory factor analysis,including medical services and social activities related distress,disease self-management related distress,disease itself related distress,complications and prognosis related distress,and social support related distress,which accounted for 67.062% of the variation.The total score of the scale and the scores of each dimension were significantly positively correlated with the scores of the Edinburgh Postnatal Depression Scale,Pregnancy-related Anxiety Scale and its three dimensions,with correlations ranged from 0.246 to 0.547(P < 0.01).The total score of the scale and the scores of each dimension were significantly positively correlated with the scores of the Diabetes Distress Scale and its four dimensions,with correlations ranged from0.467 to 0.870(P < 0.01).Cronbach’s alpha of the total scale was 0.959,Cronbach’s alpha of each dimension was 0.740-0.924.The intraclass correlation coefficient of the total scale was0.829,and the intraclass correlation coefficient of each dimension was 0.738-0.814.Conclusion: The Gestational Diabetes Mellitus Distress Scale developed in this study has good reliability and validity,and can be used to evaluate the disease-specific distress of pregnant women with gestational diabetes mellitus. |