CONSORT guidelines were adhered for reporting of this trial.
This study was a single-blind randomized controlled clinical trial with two parallel group (intervention and control groups). This study approved by the Ethics Committee of Tabriz University of Medical Sciences (code: IR.TBZMED.REC.1396.453). The population of this study includes pregnant women with gestational age of 28–32 weeks who referred to health centers of Khalkhal city, west Azerbaijan province, Iran from February to September 2018. All participants signed a written informed consent form. Only data analyser was blinded to the intervention received by the study groups.
The inclusion criteria were being pregnant with gestational age 28–32 weeks, having the first or second pregnancy, the willingness to delivery in Khalkhal’s Imam Khomeini Hospital, and lack of participation in the same classes. The exclusion criteria were high-risk pregnancies including gestational diabetes, preeclampsia, twin and multiple pregnancies, mothers with amniotic fluid and placenta disorders, fetal death, mental illnesses, and taking certain medications, having cesarean section indications, previous cesarean section, abnormal fetal presentation, pelvic stenosis, and fetal macrosomia.
Randomization & masking
Participants were assigned to two groups of intervention (recipient of distraction techniques) and control through stratified block randomization based on the number of deliveries (first delivery and second delivery) with block sizes of 4 and 6 and with a 1:1 assignment ratio. Blocking was done by a non-involved person in data collection and analysis. To conceal the allocation, the type of intervention was written on a sheet of paper and sealed in matte envelopes. Envelopes were opened by the researcher in the order of entry of the participants to the research and the type of group was identified.
Sampling started after receiving the ethics code from the Ethics Committee of Tabriz University of Medical Sciences and registering the study on the Iranian Registry of Clinical Trials site. Khalkhal, a city in northwestern Iran, has three health centers. During the sampling process, the researcher inquired about the information of pregnant mothers during the week of 28–32 through the Integrated Health System and contacted the mothers who had some inclusion criteria. Also, over a telephone call, the researcher briefed the research plan and its objectives. The participants were assessed based on the eligibility criteria and, if they were eligible and willing to participate in the study, asked to attend a health center at a specific time. In attendance, comprehensive data including the goals, importance, and benefits of participation in the study, as well as the stages of the implementation of the research were provided to pregnant women. Moreover, if they desired, the basic questionnaires including socio-demographic characteristics questionnaire, PSS and fear of childbirth questionnaire (W-DEQ version A) were completed through interviews and participants were allocated into two groups.
Counseling based on distraction techniques for controlling stress, fear, and the pain was presented to participants in the intervention group in four sessions within a week. All counseling sessions were conducted by the first author. The first session was held on the 32nd week of pregnancy. During this meeting, all participants were trying to establish friendly relations and gaining the confidence of the participants. Then, the researcher described in detail the definition of distraction technique and how it affects pain management. In the second session, several distraction techniques were explained for the intervention group; i.e., watching movies, solving table and puzzles, listening to music, illustrating child’s future, remembering memory, talking about their skills, reverse counting the numbers, counting the serum drops used during labor, and also about personal interests and experiences. In the third session, the researcher received feedback from the previous session, exercises were performed at home, and the participants were asked to do exercises including counting certain letters while watching the video and playing music, reverse counting the numbers 3 by 3 out of 1000, record the length of time they can entertain themselves with these methods, and record their interests. Based on their records, the researcher provided necessary facilities for them to use during labor. In the fourth session, stages of delivery, delivery progress, control of stress and fear using distraction techniques, birth space, and childbirth preparation were discussed, and feedback from the intervention group was received. All participants in the intervention and control groups were asked to attend the health center at week 36 and the W-DEQ was completed by interviewing them. For participants in the control group, after the completion of the W-DEQ, training was given about signs of delivery, the stages of delivery and the appropriate time for a referral to the hospital. In all sessions, the principles of counseling were thoroughly followed. Then, all the participants were given a phone number of the researcher to contact the researcher in the event of labor pain and referral to the hospital. The researcher attended the hospital and used the VAS scale to record the pain of the participants every hour during the active phase of labor. Then, the perceived stress questionnaire was completed after the participant’s admission in the delivery department at the beginning of the active phase of labor through interview. The intervention group, based on their interest in the third session, was provided by distraction facilities such as movies, music, table, puzzle, book, and more. The researcher was active alongside the mother during the entire phase of the active phase and all distraction techniques by the participants including reverse counting the numbers, counting the serum drops, memorizing, illustrating, etc. were conducted in the presence of the researcher. For mothers, their favorite film was played and they were asked to carefully watch the movie and count certain letters when watching them. The control group received routine care.
The primary outcomes included severity of labor pain and perceived stress that was measured by VAS and PSS, respectively before intervention and in the active phase of labor. VAS is a graded ruler of 10 cm in length, in which the patient should determine his own assessment of pain on this graded line from zero (painless) to 10 (the most extreme pain imaginable). Based on this scale, the score zero denotes the labor without pain, 1–3 as mild, 6–4 as average, 9–7 as severe, and 9–10 as very severe pain levels . PSS consists of 14 items and scores are based on 5-item Likert as follows: never = 0, almost never = 1, sometimes = 2, often = 3, and many times = 4 points. The items 4–5–6-7, 9, 10, and 13 are scored inverse (never = 4, many times = 0). The lowest score is 0 and the highest score is 56. A higher score indicates more perceived stress  . The reliability of the Persian version of this questionnaire was calculated by Bastani et al., by the internal consistency method. They obtained a Cronbach’s alpha coefficient of 74% for this questionnaire .
The secondary outcomes included fear of childbirth, duration of active phase of labor and second stage of delivery, total length of delivery, first minute Apgar score and oxytocin consumption. The W-DEQ-Version A was used to assess the fear from childbirth before intervention and again at the 36th week of pregnancy. This questionnaire has 33 questions. Mothers identify their personal feelings based on a 6-item Likert scale (at all = 0, very low = 1, low = 2, average = 3, high = 4, and very high = 5). Questions 1, 4, 5, 9, 10, 13, 14–16–17-18, 21–22-23, 26, 28–29-30 are scored in reverse. The score range is 0 to 165 and a higher score indicates more fear . The reliability of the Persian version of this questionnaire was assessed by Abedi et al., who reported the Cronbach’s alpha of 0.64 .
The length of delivery stages, first minute Apgar score and oxytocin consumption were recorded in the partograph chart during labor and childbirth by researcher.
The sample size in this study was calculated based on both pain and stress variables using G-Power software. According to the results of the study by Madadi et al. (2016) regarding the pain variable, taking m1 = 8.9 (pain before the intervention), m2 = 7.9 (pain after intervention), sd1 = 1.2, sd2 = 0.9, α = 0.05, and Power = 95% were calculated to be 31 . Based on the results of Mirghafourvand et al. (2014) on the perceived stress variable and taken into account m1 = 26.2 (perceived stress before intervention), with a 20% reduction in mean perceived stress score due to the intervention (m2 = 19.65), sd1 = Sd2 = 5.5, α = 0.05 and power = 95% was calculated to be 28 . Since the sample size was calculated based on the pain variable was more, considering the 10% attrition, the final sample size was calculated to be 34.
Statistical analysis of the present study was conducted using SPSS 24 software. The normality of quantitative data was investigated using the Kormogrov-Smirnov test. The results showed that the duration of the second stage of delivery and the pain score did not have a normal distribution. The Chi-square, Chi-square for trend, Independent t and Fisher’s exact tests were used for assessing the consistency of the two groups in terms of socio-demographic characteristics. To compare the mean perceived stress score and childbirth fear, independent t-test was used before intervention and ANCOVA test with adjustment of baseline values, and stratification factor (first delivery or second delivery) after the intervention. To compare the duration of the active phase and the total length of delivery, independent t-test was used and to compare the length of the second stage of delivery and the mean pain during labor in the two groups, Mann-Whitney U test was used. Chi-square test was applied for comparing frequency of oxytocin consumption in the two intervention and control groups. Fisher’s exact test was used to compare the Apgar score at the first minute (Those who had cesarean section, their first-minute Apgar score was assessed in the operating room). The significance level for statistical tests was considered less than 0.05. All analyses were performed based on intention to treat.