Clinical trial NCT06955312: The Effect of Paint-by-Numbers Activity on Stress and Prenatal Attachment in High-Risk Pregnancies
Official title: The Effect of Paint-by-Numbers Activity on Stress and Prenatal Attachment in High-Risk Pregnancies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High-Risk Pregnancies
Keywords: High-risk pregnancy
Prenatal attachment
Stress management
Paint-by-numbers activity
Randomized controlled trial
Lead sponsor: Erzurum Technical University
Sponsor class: OTHER
Collaborators: name: Scientific Research Projects Coordination Unit
First posted: 2025-05-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The G\*Power program (version 3.1.9.3) was used to calculate the sample size, and Cohen's standard effect size was considered for determining the sample size. According to Cohen, an effect size of 0.20 is classified as "small," 0.50 as "medium," and 0.80 as "large." In this study, Cohen's effect size was assumed to be 0.80 to determine the minimum required sample size. Based on this effect size, the Type I error was set at 0.05, and the power of the test was 0.80 (α = 0.05, 1-β = 0.80, effect size = 0.80). As a result, the required sample size for the study was determined to be 52 participants (n = 26 per group) for an equal distribution between groups. Considering potential participant dropout, the final sample size was determined to be 60 participants (n = 30 per group).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pregnancy, a physiological state, is defined both as a turning point and a developmental crisis . Pregnancy directly affects maternal and child health, and in cases of complications, it can lead to morbidity and mortality, particularly in developing countries . According to data from the World Health Organization (WHO), approximately 830 women worldwide die daily due to preventable pregnancy- and childbirth-related causes, with 99% of all maternal deaths occurring in developing countries, including Turkey (https://www.who.int/news-room/fact-sheets/detail/maternal-mortality).

In Turkey, the 2005 National Maternal Mortality Study reported a maternal mortality rate of 28.5 per 100,000 live births. This study revealed that 49.3% of pregnancy-related deaths and 61.6% of maternal deaths were due to preventable causes Hemorrhage, infection, and preeclampsia/eclampsia are among the leading causes of maternal mortality both in Turkey and globally . This significant issue is included in the Sustainable Development Goals (2016-2030) as a target to reduce global maternal mortality

High-risk pregnancy refers to conditions where maternal, fetal, or neonatal health is partially or entirely at risk . According to the 2013 Turkey Demographic and Health Survey (TNSA), 63% of pregnant women aged 18-34 in Turkey fall into at least one risk category. High-risk pregnancies are associated with various physiological and psychological challenges, negatively impacting maternal, infant, and family health . In addition to posing life-threatening risks, high-risk pregnancies represent a crisis related to fertility . When a pregnancy is high-risk, emotional distress increases due to maternal or fetal complications . Compared to low-risk pregnancies, high-risk pregnant women experience significantly higher stress regarding their own and their baby's health .

Stressors experienced by high-risk pregnant women include receiving a high-risk pregnancy diagnosis, unplanned pregnancy, pregnancy complications, fetal abnormalities, childbirth fears, adolescent pregnancies, marital issues, lack of social support, economic concerns, postpartum problems, and hospitalization . Perceived stress during pregnancy is highly significant for pregnancy outcomes . Pregnancy-related stress has been characterized as a stronger form of stress than general stress due to its ability to trigger heightened physiological arousal . This can have adverse effects, increasing maternal and fetal morbidity and mortality risks . Stress may elevate oxytocin and prostaglandin hormone levels while reducing beta-endorphin and progesterone levels, leading to birth complications or adverse birth outcomes .

Stress during pregnancy has been associated with negative birth outcomes, including preterm labor, spontaneous abortion, neonatal malformations, and growth retardation . Additionally, stress can negatively impact parental attachment to the fetus and newborn . There is a bidirectional relationship between attachment and a woman's psychosocial well-being. Prenatal attachment is influenced by the mother's psychosocial state, and a lack of attachment can negatively affect her mental well-being. Literature suggests a link between prenatal attachment and long-term maternal depression . A study highlighting the potential adverse effects of stress on prenatal attachment in high-risk pregnancies emphasized the importance of supporting prenatal attachment to prevent postpartum issues such as anxiety and depression .

Detailed description: Stress, which has adverse effects even in the postpartum period, is among the modifiable risk factors in high-risk pregnancies. A study published in The Lancet on maternal health reported that at least 40 million women worldwide experience long-term health problems due to childbirth. The study highlighted persistent issues such as anxiety (9-24%), depression (11-17%), and tokophobia (6-15%) months or even years after delivery (Vogel et al., 2024). Many of these conditions are thought to stem from poorly managed stress. A study in Nepal identified stressful life events as contributing factors to postpartum depression symptoms .

Negative pregnancy outcomes not only affect maternal and infant health but also place a significant economic burden on countries. For instance, in the United States, the annual costs associated with preterm birth-including medical care, parental work loss, and specialized education-are estimated at $26 billion. Literature underscores that effective care during pregnancy and childbirth is a crucial preventive factor in identifying risks and preventing complications that could lead to long-term health issues. The International Council of Nurses (ICN) states that nurses play a vital role in educating individuals about what they need to maintain good health.

Hospitalization can create stress for high-risk pregnant women, highlighting the importance of introducing activities that help manage stress during this period. A review of the literature revealed no randomized controlled studies examining the effects of a paint-by-numbers activity on perceived stress and prenatal attachment in hospitalized high-risk pregnant women. This study aims to investigate the effects of a paint-by-numbers activity on stress and prenatal attachment among high-risk pregnant women receiving inpatient care at Erzurum City Hospital. It is anticipated that this study will contribute to reducing stress and enhancing prenatal attachment among women with high-risk pregnancies. Additionally, it is expected to raise awareness among healthcare providers, particularly nurses, about incorporating such activities into their care practices.

Eligibility criteria: Inclusion Criteria:

* Having a high-risk pregnancy
* Being at or beyond the 20th week of pregnancy
* Being hospitalized for at least 4 days for high-risk pregnancy monitoring
* Being open to communication and collaboration
* Being literate in Turkish
* Being over 18 years of age
* Volunteering to participate in the study

Exclusion Criteria:

* Being under 18 years of age

Primary outcomes:
measure: Perceived Stress Level
timeFrame: 10-15 Minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Erzurum Technical University Faculty of Health Sciences
name: Ayşe METİN, Assistant Professor (Dr.)
role: STUDY_DIRECTOR
References:
citation: Vogel JP, Jung J, Lavin T, Simpson G, Kluwgant D, Abalos E, Diaz V, Downe S, Filippi V, Gallos I, Galadanci H, Katageri G, Homer CSE, Hofmeyr GJ, Liabsuetrakul T, Morhason-Bello IO, Osoti A, Souza JP, Thakar R, Thangaratinam S, Oladapo OT. Neglected medium-term and long-term consequences of labour and childbirth: a systematic analysis of the burden, recommended practices, and a way forward. Lancet Glob Health. 2024 Feb;12(2):e317-e330. doi: 10.1016/S2214-109X(23)00454-0. Epub 2023 Dec 6.
citation: Arslan, S., Okcu, G., Coşkun, A., & Temiz, F. (2019). Women'sperceptıon