| 基本情報/Basic information |
| 一般向け試験名/Public title |
妊娠中及び出産後の女性を対象とした子育て応援サービスのQOL及び産後うつ改善効果及びサービス検討に関する研究 |
A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women. |
| 一般向け試験名略称/Acronym |
妊娠中及び出産後の女性を対象とした子育て応援サービスのQOL及び産後うつ改善効果及びサービス検討に関する研究 |
A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women. |
| 科学的試験名/Scientific Title |
妊娠中及び出産後の女性を対象とした子育て応援サービスのQOL及び産後うつ改善効果及びサービス検討に関する研究 |
A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women. |
| 科学的試験名略称/Scientific Title:Acronym |
妊娠中及び出産後の女性を対象とした子育て応援サービスのQOL及び産後うつ改善効果及びサービス検討に関する研究 |
A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women. |
| 試験実施地域/Region |
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| 目的/Objectives |
| 目的1/Narrative objectives1 |
本研究の目的は，子育て応援サービス(コミュニケーションロボット(BOCCO emo))を妊娠中から出産後まで継続的に使用することによるQOL及び産後うつに対する改善効果を探索すること，本サービスの実装可能性について検討することである. |
The purpose of this study is to investigate the effects of continuous use of the childcare support service (communication robot (BOCCO emo)) from pregnancy to postpartum on quality of life and prevent and improve depressive condition, and to conduct a feasibility investigation of the service. |
| 目的2/Basic objectives2 |
有効性/Efficacy |
| 目的2 -その他詳細/Basic objectives -Others |
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| 試験の性質1/Trial characteristics_1 |
探索的/Exploratory |
| 試験の性質2/Trial characteristics_2 |
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| 試験のフェーズ/Developmental phase |
該当せず/Not applicable |
| 評価/Assessment |
| 主要アウトカム評価項目/Primary outcomes |
WHO-5（精神健康状態表簡易版）総スコアのベースライン時から各時点までの変化量(妊娠36週、産後1か月、産後3か月). |
WHO-5(simplified Japanese version of the WHO-Five Well-being Index) change in total score from baseline to each time point(36 weeks gestation, 1 and 3 months postpartum).
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| 副次アウトカム評価項目/Key secondary outcomes |
(1)EPDS(エジンバラ産後うつ病質問票)総スコアのベースライン時から各時点までの変化量(妊娠36週、産後1か月、産後3か月).
(2)地域の母子保健センターへ相談した件数.
(3)サービス等に関するアンケート回答によるサービス全体の満足度，継続利用，推奨度，使用頻度，サービス金額への意向，金融知識・保険相談ニーズ. |
(1)EPDS(Edinburgh Postnatal Depression Scale) change in total score from baseline to each time point.
(2)Number of consultations with local maternal and child health centers(36 weeks gestation, 1 and 3 months postpartum).
(3)Satisfaction with overall service, continued use, recommendation, frequency of use, intention to pay for service, financial knowledge and insurance consultation needs based on questionnaire responses regarding service, etc. |
| 介入/Intervention |
| 群数/No. of arms |
2 |
| 介入の目的/Purpose of intervention |
治療・ケア/Treatment |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
介入群へは，同意が確認された後，妊娠30週にコミュニケーションロボット（BOCCO emo）の送付を行い，到着次第介入を開始する. BOCCO emo専用アプリケーションをご自身のスマートフォンにダウンロードし，産後3カ月時までコミュニケーションロボットを含む子育て応援サービスの利用を継続する. 子育て応援サービスに付帯するサービスとして，オンラインカウンセリング（上限2回），オンライン助産師・保育士相談（上限2回），オンライン診療（予約までは無料，診療は実費）なども利用することができる. 研究対象者の好みに応じて利用頻度や利用するサービスを選択することができる. |
The intervention group will receive the communication robot (BOCCO emo) at 30 weeks of pregnancy after consent is confirmed, and the intervention will start as soon as it arrives. The service will continue to be available until 3 months after delivery. In addition to the parenting support services, online counseling (up to 2 times), online midwife/nursery consultation (up to 2 times), and online medical care (free of charge up to the appointment, actual cost for medical care) are also available. The frequency of use and services can be selected according to the preferences of the research subjects. |
| 介入2/Interventions/Control_2 |
非介入群は, 子育て応援サービスを使用しない. |
The control group will not use the parenting support services. |
| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
女/Female |
| 選択基準/Key inclusion criteria |
以下の基準を全て満たす方を本研究の対象とする.
(1)同意取得時点において妊娠中期であり、第一子妊娠中の方.
(2)本研究の内容に賛同し，研究への参加に対する同意が本人から得られた方.
(3)ご自宅にWi-Fi環境があり，研究期間を通じてコミュニケーションロボットを自宅に設置し，Wi-Fi接続可能な方.
(4)ご自身のスマートフォンに専用アプリケーションをダウンロードし，使用可能な方.
(5)同意説明文書，アンケートに記載されている日本語が理解できる方. |
Persons who meet all of the following criteria will be considered for this study.
(1) The women who are in the second trimester of pregnancy and pregnant with their first child at the time of obtaining consent.
(2) Persons who agree with the content of this study and have given their consent to participate in the study.
(3) Have a Wi-Fi environment at home and be able to set up the communication robot at home and connect to Wi-Fi throughout the study period.
(4) Persons who are able to download and use the dedicated application on their own smartphones.
(5) Persons who can understand the Japanese language described in the consent document and the questionnaire. |
| 除外基準/Key exclusion criteria |
以下のいずれかの基準に該当する方は本研究の対象外とする.
(1)代諾者を要する方.
(2)産後3カ月間に実母や実父・義母や義父・支援者等と同居予定の方.
(3)うつ病，精神疾患治療中の方.
(4)その他，研究責任者又は研究分担者が本研究への参加を不適当と判断した方. |
Persons who meet any of the following criteria will be excluded from this study.
(1) Persons who require a surrogate.
(2) Persons who plan to live with their mother, father, mother-in-law, father-in-law, or supporter during the first 3 months after childbirth.
(3) Persons who are under treatment for depression or psychiatric disorders.
(4) Other persons who are judged to be inappropriate to participate in this study by the principal investigator or co-Investigators. |
| 目標参加者数/Target sample size |
100 |
UMIN-CTR 臨床試験登録情報の閲覧