The effect of distraction techniques on pain and stress during labor: a randomized controlled clinical 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.

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 [30]. 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 [31] . 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 [32].

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 [33]. The reliability of the Persian version of this questionnaire was assessed by Abedi et al., who reported the Cronbach’s alpha of 0.64 [34].

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 [35]. 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 [36]. 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.

Before intervention, the mean (SD) of the perceived stress score was 15.1 (8.0) in the distraction techniques group and 15.6 (1.6) in the control group. Moreover, at the beginning of the active phase of labor, the perceived stress score was 11.8 (5.7) and 15.2 (7.1) in the intervention and control groups, respectively. Before the intervention, there was no statistically significant difference between the two groups (P = 0.717), but in the active phase of labor based on ANCOVA test and with adjusting the baseline score, the mean score of perceived stress in the distraction techniques group was significantly less than the control group (AMD = − 2.3; 95% CI: − 0.6 to − 0.8, P = 0.01) (Table 2).

The mean (SD) of labor pain severity was 6.2 (1.4) in the distraction techniques group and 7.5 (1.4) in the control group, which was significantly lower in the intervention group than in the control group (P < 0.001) (Table 3).

There was no significant difference between women with gravida 1 and 2 in terms of mean severity of labor pain (P = 0.818) and post-intervention mean score of perceived stress (P = 0.338).

The preintervention mean (SD) score of childbirth fear was 38.3 (22.9) in the distraction techniques group and 46.3 (17.1) in the control group. Also, in the 36th week of gestation, it was 29.1 (18.9) in the distraction techniques group and 39.1 (29.6) in the control group. There was no statistically significant difference between the two groups before the intervention (P = 0.117), but in the 36th week of pregnancy, according to ANCOVA test with adjusting the preintervention score, the mean score of the fear of childbirth in the distraction techniques group was less than that of the control group, but the difference was not statistically significant (AMD: 5.4; 95% CI: − 2.4 to 13.0; P = 0.117) (Table 2).

The duration of the active phase (P = 0.504), the second stage of delivery (P = 0.928), and the total duration of delivery (P = 0.520) were lower in the intervention group, but this difference was not statistically significant (Table 3). There was no significant difference between the two groups in terms of the first minute Apgar score (P = 1.000) and the frequency of oxytocin consumption (P = 0.622) (Table 4).

One of the strengths of this study is the implementation of distraction techniques intervention on labor pain and stress, for the first time, and all the principles of clinical trial, including random allocation, and allocation concealment, were observed to prevent selection bias. Existence of a private room for counseling in health care centers and a single LDR (Labor, Delivery and Recovery) room in the hospital delivery unit and also staff and obstetricians collaboration were another strengths of this study. Using standard questionnaires to measure perceived stress, pain, and fear of childbirth are other strengths of this study.

One of the limitations of this research is that it was conducted only on women with first and second pregnancies, therefore, the results cannot be generalized to women with third or higher pregnancies. Moreover, considering that the intervention and data collection was done by the first author, there was no possibility of blinding of participants and data collector. It is suggested that the effect of distraction techniques on the severity of fear and stress in patients before cesarean section, Posttraumatic Stress Disorder (PTSD) and etc. to be studied.