Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Perspectives of parents on infant sleep |
The semi- structured individual interviews will be conducted with mothers and fathers of infants with and without sleep problems. Both parents of an infant will be interviewed in different sessions to detect any discrepancies between their opinions. The topic guide will include parental views, perceptions and interpretations of their infants' sleep and expectations regarding interventions. |
Baseline |
|
Secondary |
Parental anxiety |
• Parental anxiety will be measured with Generalized anxiety scale-7. It is a seven item scale developed to screen for anxiety in general in primary care settings. The questionnaire score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. Cut off score for Turkish validation has been set at 8. |
Baseline |
|
Secondary |
• Parental depression symptoms |
• Parental depression symptoms will be measured with Patient Health Questionnaire-9. It is a nine item scale used to screen for the presence and severity of depressive symptoms. As a severity measure, the PHQ-9 score ranges from 0 to 27, with each of the nine items scored from 0 (not at all) to 3 (nearly every day). A score of 10 or above indicates depressive disorder. Turkish validation has been done. |
Baseline |
|
Secondary |
• Global relationship |
• Global relationship will be measured with Relationship Assessment Scale. This is a brief measure of global relationship satisfaction, which consists of seven items, each rated on a five-point Likert scale, ranging from 1 (not well), to 5 (very well). The scale is suitable to use with any individuals who are in an intimate relationship such as married couples or cohabiting couples. |
baseline |
|
Secondary |
• Married-life satisfaction scale |
• Married-life satisfaction scale is a 5-item scale developed to measure married life satisfaction. Higher scores indicate better marital satisfaction. |
baseline |
|
Secondary |
Parental Sleep quality |
• Parental sleep quality will be measured with Pittsburgh sleep quality index. It is a questionnaire which assesses sleep disturbances over a 1-month time interval. If the PUKI global score is greater than 5, it indicates poor sleep quality. Turkish validation has been done. |
Baseline |
|
Secondary |
Infant sleep wake patterns |
• Infants sleep wake patterns will be measured with actigraphy. Actigraphy is a wrist-watch like device that continuously measures motion and estimates sleep-wake patterns by measuring motion in natural settings. It is a valid method to objectively assess infants' sleep. Sleep wake patterns will be assessed by Philips Respironics Mini-Mitter Actiwatch-2 for 3 days at home environment and sleep diaries within 5-minute intervals will be filled out by parents simultaneously. The following actigraphic sleep metrics will be used: 1) wake after sleep onset (WASO); 1) sleep of latency (SOL); and 3) number of awakenings (NW), sleep duration, sleep efficiency. |
Baseline |
|
Secondary |
Infant sleep parameters |
• Infant sleep parameters will be measured by Expanded-Brief Infant Sleep Questionnaire (BISQ) :BISQ is a screening questionnaire for sleep in infants and young children. Variables include nocturnal sleep duration, daytime sleep duration, number of night awakenings, duration of night time wakefulness, nocturnal sleep onset time, settling time, method of falling asleep, location of sleep. If the child woke up more than 3 times per night, spent more than 1 hour in wakefulness during the night, or spent less than 9 hours in sleep (day and night), then they were considered as poor sleepers |
Baseline |
|