Anxiety Clinical Trial
Official title:
The Effect of Lullaby Intervention on Anxiety and Prenatal Attachment in Women With High-risk Pregnancy: A Randomised Controlled Study
NCT number | NCT04064320 |
Other study ID # | 363 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 6, 2017 |
Est. completion date | December 5, 2018 |
Verified date | November 2020 |
Source | Ondokuz Mayis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of present study was to investigate the effect of lullaby intervention on anxiety and prenatal attachment in women with high-risk pregnancy. The study involved women with high-risk pregnancy who were assigned randomly to the intervention (n=30) or control (n=30) groups in a state hospital in Turkey. For two successive days, the intervention group listened to lullabies for 20 minutes once a day, meanwhile touched the abdomen and thought about their babies, but the control group did not. Data from the outcomes of anxiety and attachment were collected at baseline and at the end of the second day. Vital findings were measured on each study day, both before and after the lullaby intervention/usual care.
Status | Completed |
Enrollment | 76 |
Est. completion date | December 5, 2018 |
Est. primary completion date | December 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Hospitalization due to high-risk pregnancy - 19 years and older - Pregnancy duration longer than 28 weeks. - Singleton pregnancy. - Duration of hospitalization 24 hours minimum. - Ability to read and write and to comprehend. - Speaking Turkish. Exclusion Criteria: - Hospital admission due to severe preeclampsia, eclampsia or ablatio placenta. - Presence of mental or cognitive disorders. - Being under psychiatric treatment. - Vision or hearing impairments. - Fetal deformity or anomalies such as congenital diseases |
Country | Name | City | State |
---|---|---|---|
Turkey | Ondokuz Mayis University, Faculty of Health Sciences | Samsun |
Lead Sponsor | Collaborator |
---|---|
Ondokuz Mayis University |
Turkey,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anxiety change | As assessed by the State-Trait Anxiety Inventory (STAI) STAI consists of two scales, a total of 40 self-reported items. The State Anxiety Scale only used in this study, consists of 20 straight and inverse scored terms, and is scored between 20 and 80 in a likert type scoring between 1 and 4. High scores indicate high anxiety levels. | At baseline and at the end of the 2nd day of study, anxiety was assessed. | |
Primary | Prenatal attachment change | As assessed by the Prenatal Attachment Inventory (PAI) PAI which is a likert type scale, has 21-item with four scores (1-4) and the total score is 21-84. A higher scores indicate higher levels of attachment. | At baseline and at the end of the 2nd day of study, prenatal attachment was assessed. | |
Secondary | Change in Respiratory Rate | The respiratory rate was measured by observing the chest and count the number of respirations out loud for one full minute using a digital watch while at bed rest. One respiration consists of one complete rise and fall of the chest (inhalation and exhalation of air). | At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care | |
Secondary | Change in Heart Rate | The heart rate was measured using a digital sphygmomanometer. | At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care | |
Secondary | Change in Systolic Blood Pressure | The systolic blood pressure was measured using a digital sphygmomanometer and recorded in mmHg. | At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care | |
Secondary | Change in Diastolic Blood Pressure | The diastolic blood pressure was measured using a digital sphygmomanometer and recorded in mmHg. | At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care |
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